Efficacy of Mamsyadi Ghana capsule in Insomnia Disorder – A randomized controlled trial

Abstract

Background

Insomnia disorder is a common sleep disorder. Mamsyadi Ghana Capsule (Ayurveda medication) is assessed for its role in the management of Insomnia disorder.

Objective

The study was planned to evaluate the efficacy of Mamsyadi Ghana Capsule in the management of Insomnia disorder

Methods

50 patients attending the OPD of the institute, meeting the diagnostic criteria of Insomnia Disorder (DSM 5) of age group 20–80 years of both sex participated in the study. They were randomly divided and Tagara Churna group (TC) received Tagara Churna (Valeriana wallichi DC) 4 gram and Mamsyadi Ghana group (MG) received Mamsyadi Ghana Capsule 500 mg respectively thrice a day for 30 days. Evaluations were done through Insomnia severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness scale (ESS), Sleep diary recordings of past 15 days and depression Anxiety and Stress Scale (DASS). Clinical assessments were on 15th and 30th day. Blood parameters like haemoglobin, liver function tests, serum creatinine were evaluated at baseline and post study.

Results

Study showed that Mamsyadi Ghana Capsule produced significant improvement compared to Tagara Churna in ISI and ESS (p = 0.01) and effect size was large. Both interventions were comparable in PSQI, DASS, sleep diary variables. Both the interventions produced significant improvement in ISI, ESS, PSQI, DASS (p < 0.001) and sleep diary variables on within group comparison. Serum Creatinine and Liver function tests showed that both the interventions had good safety profile.

Conclusion

Study showed that Mamsyadi Ghana Capsule is better than the Tagara Churna in Insomnia Disorder and both showed anxiolytic and antidepressant effect.

Highlights

• •One of the major Ayurveda interventional study on Insomnia Disorder.
• •Very few clinical Ayurveda studies on Insomnia disorder as per DSM V.
• •Randomized controlled trial.
• •Assessing through standard clinical assessment scales of Insomnia severity, qualitative and quantitative sleep, day time sleepiness.
• •Assessment of Depression, Anxiety and Stress.

1. Introduction

Insomnia is one of the common chronic, debilitating sleep disorder having a significant economic repercussions [1]. Insomnia is the subjective assessment of factors including initiation of sleep , maintenance of sleep , duration and quality of sleep , sleep disturbance occurs in spite of opportunity for sleep and it causes daytime disturbance [2]. Insomnia causes repeated awakenings in night time along with difficulty in getting back to sleep, it makes the affected awake even before the desire to get up in the morning [3,4]. Insomnia has a significant public health issue [5] leading to decreased quality of life and work place accidents.

Insomnia amongst adults affects around 10% of total population [6] and is associated to chronic fatigue [7], alteration of sustained attention [8], poor grade of working memory [9] and decreased quality of life [10]. One out of every twenty Indian suffers from sleep disorder. In India 6.5% of women & 4.3% of men suffers from disturbed sleep [11]. In 20yrs, over 260 million people will experience sleep disorders [12]. Insomnia disorder is the most prevalent sleep disorder affecting 6%–20% [13,14]. Insomnia has associations with other disorders like depressive disorders, anxiety disorders, suicide, substance abuse, decreased immune functioning and cardiovascular disease [15]. Chronic insomnia reduces quality of life, causes high absenteeism, increased social burden and mortality risk [16,17]. Long lasting insomnia is also associated with increased incidence for psychiatric and substance use disorders, and aggravates the existing disease condition [18,19]. Insomnia is considered to be a public health issue and is yet to receive adequate consideration and remains to be effectively treated [20].

Conventional treatment for insomnia includes the use of pharmacological agents like benzodiazepines, non-benzodiazepine hypnotics and sedatives. Non-pharmacological treatment approaches include Acupuncture and Cognitive Behavioural Therapies. Conventional hypnotic medications increase total sleep time at night and reduce sleep latency [21,22], however have some risk of overdose, tolerance, addiction, day time sedation, problematic withdrawal symptoms [23]. Public health burden of insomnia still needs to be properly addressed. Alternative and complimentary medicines remain to be explored yet for their possible beneficial role. Among the herbs, meta analysis study has showed that the valerian [24] to be safe and effective in Insomnia. Studies assessing the efficacy of Ayurvedic medications in insomnia are lacking.

Insomnia as a disease is dealt under the broad heading of Anidra in Ayurveda. Sleep is due to multi components like fatigue (causing sensory and motor dissociation from mind), night period (kapha and tama producing obstruction to channels) , disturbance to Chetana sthana (by tamas) [25]. Causes of Anidra are emotional disturbances (like fear, anxiety, anger), excessive physical activities (like exercise, fasting), excess of therapeutic process (like purgation, emesis, smoking, blood letting), old age, vataja nanatmaja vyadhi [26]. Pathophysiology of Anidra includes Tama, Raja dosha along with vata and pitta dosha in their deranged states. Srotas involved are manovaha and vatavaha. Derangement in rasa and other dhatus are observed.

Ayurveda physicians widely use Tagara churna (Valeriana wallichi DC) [27] and it has shown beneficial effect in Primary Insomnia [28]. Mamsyadi kwatha [29] is an Ayurveda classical formulation and is widely used by Ayurveda clinicians in management of Insomnia. Our clinical experience has shown beneficial effect of Mamsyadi kwatha in Insomnia disorder. Mamsyadi Ghana Capsules is a solidified aqueous extract of Mamsyadi kwatha and has greater advantage like palatability, transport and shelf life. Hence current study was planned to evaluate the efficacy of Mamsyadi Ghana Capsule in the management of Insomnia disorder.

2. Materials and methods

The patient recruitment was from the outpatient department of the institute. The CONSORT statement guidelines [30] were followed in the reporting of the study.

2.1. Participants

Total of 50 patients diagnosed with Insomnia Disorder according to DSM V Diagnostic Criteria were enrolled in the study. These subjects were recruited from patients visiting outpatient department of KAHER's Shri BMK Ayurveda hospital Belagavi, Karnataka, India.

2.1.1. Inclusion criteria

The patients of both sex between 20 and 80 years of age fulfilling the diagnostic criteria of Insomnia disorder (DSM V) and those who are suffering from insomnia for a period of minimum 3 months.

2.1.2. Exclusion criteria

Patients suffering from psychiatric disorders like schizophrenia, major depressive disorder, psychosis, anxiety disorders, alcohol dependency or drug dependency, other sleep disorders like narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or parasomnia , other illness like epilepsy, asthma, chronic renal failure , Use of hypnotics by prescription, psychotherapy within the past 4 weeks, pregnant and lactating female patients were excluded from the study.

2.1.3. Screening methods

All study patients were subjected to a detailed clinical evaluation and systematic data collection was carried out. Laboratory investigations were carried out at clinical laboratory of the institute at baseline and at the end of intervention.

2.2. Research design

The study was a randomized, controlled, parallel group comparative design clinical study. Random numbers were generated from online software named as “Random Number Generator. Block size was 2. The patients were allocated in 1:1 ratio in control and intervention groups. Sample size was calculated from a previous study [31]. Total Sample was 50, 25 in each arm with 5% alpha error and 80% power.

2.2.1. Intervention

All the patients (n = 50) were randomly divided into two groups. Tagara Churna group (TC) (n = 25) received Tagara Churna 4 gm thrice a day for 30 days. Mamsyadi Ghana group (MG) (n = 25) received Mamsyadi Ghana Capsule 500 mg thrice a day for 30 days. Both the interventions were administered with milk after food intake. Converting Mamsyadi Kwatha (decoction) into ghana vati dosage form (solidified aqueous extract) may not alter the property of the formulation to a major extent but may help in increasing the shelf life and convenience to the patients [32]. This form of drug is palatable, easy to store, transport, and have longer shelf life. Preparation of Tagara churna and Mamsyadi Ghana capsule were carried out at GMP certified KLE Ayurveda Pharmacy, Khasbhag, Belagavi Karnataka. Authentication of all raw material was carried out at Central Research Facility, AYUSH approved ASU drug testing laboratory. Each of raw materials and finished product were subjected to Qualitative analysis as per API (Ayurvedic Pharmacopeia of India) guidelines. Raw drugs (ash, extractive values and loss on drying), finished product assessments were done. For the medicine in the powder form (Tagara churna and Mamsyadi kwatha powder), ash values and loss on drying were assessed. Later capsule filling of Mamsyadi kwatha powder was carried out. Follow up was on every 15th day and duration of intervention was for 30 days.

Study details like design and nature were explained to patients, and informed consent was obtained prior to study. The study was approved by the Institutional Ethics Committee (Protocol BMK/17/PG/KC/1, KAHER's BMK Ayurveda Mahavidyalaya Belagavi, Date of Approval March 20, 2018 and CTRI Registration Number CTRI/2018/08/015,260). Data collection was from march 2019 to march 2020. Patients were asked to adhere to the treatment protocol during the study. Any clinical or sub clinical manifestations either new or existing causing considerable distress were evaluated for the possible adverse events. Patients were informed to report the adverse events at the earliest to the investigators if any.

2.3. Criteria for assessment

2.3.1. Primary outcome

The primary outcome was evaluated by the Standard Scale Insomnia severity Index as Question Rating Scale. (ISI) [33].

2.3.2. Secondary outcome

The secondary outcomes Considered to be Pittsburgh Sleep Quality Index (PSQI) [34], Sleep diary [35] (daily detailed recording of 15 days), Epworth Sleepiness scale (ESS) [36], Depression Anxiety and Stress Scale (DASS) [37]. Blood parameters like Haemoglobin, Serum creatinine, Liver function tests like Total Protein, Globulin, Albumin, Albumin Globulin ratio (A:G Ratio), Total and Direct Bilirubin, Alanine aminotransferase (AST), Aspartate aminotransferase (AST), Alkaline Phosphatase were assessed at pre and post study.

2.4. Statistical methods

All the statistical analysis were carried out in SPSS Version 25.0. Homogenecity of the data across the groups was assessed by the χ2 test. Across different time points Comparison between groups was assessed by repeated measure ANOVA test and within group comparison was carried out by Bonferroni post-hoc test. Amongst the objective parameters, dependent and independent paired T test were applied. Values are reported as mean ± 1 standard deviation. Effect size in the study was calculated by Partial Eta Square method. Effect of over all treatment was evaluated through outcome from base line to 30th day. Effect size interpretation was 0–0.2 minimal, 0.2–0.5 was small, 0.5 to 0.8 was medium and above 0.8 was large effect [38] size. Statistically significance was set at p < 0.05.

3. Results

Total patients recruited in the study were 50. Amongst which 25 patients from TC group and 24 patients from MG group completed the study. A patient from MG group dropped out because of intercurrent illness (fever) (Fig. 1).

Fig. 1.

Subject flow chart through the study.

3.1. Patient profile

Mean age of the patients was 51.6 years. Majority of patients in the study were female (58%), middle socioeconomic status (86%), primary school educated (40%), married (96%), no family history of insomnia or psychiatric illness (96%), Mean duration of illness was 1.58 years, Pitta Kapha prakurti (42%), Mean BMI was 23.51 and mean weight was 64.26 kgs. The mean age (p = 0.6), gender (p = 0.21), socio economic status (p = 0.22), marital status (p = 1), education (p = 0.25), prakurti (p = 0.63), duration of illness (p = 0.28), Diastolic BP (p = 0.24) were comparable between groups (Table 1). Clinical assessments like ISI, PSQI, ESS, DASS (Total), DASS (Depression), DASS (Anxiety), DASS (Stress), (Table 2), Haemoglobin (p = 0.28), Serum creatinine (p = 0.64), Liver function tests like Bilirubin total (p = 0.44), Bilirubin direct (p = 0.31), Aspartate Amino transferase (p = 0.29), Alanine Amino transferase (p = 0.16), Alkaline phosphatase (p = 0.10), total protein (p = 0.75), AG ratio (p = 0.14), albumin (p = 0.60) (Table 4) were comparable between the groups. However, baseline weight (p = 0.009), body mass index (p = 0.005) and Systolic BP (p = 0.021) showed difference between groups. BMI was in lean and overweight category as per the consensus guidelines for India. Systolic BP was in normal ranges in both the groups.

Table 1.

Patient profile

Sr. No.	Clinical profile		TC group (n = 25)	MG group (n = 25)	p
1.	Age (Years)		50.52 ± 12.75	52.28 ± 11.22	0.6
2.	Gender	Male	11	9	0.21
		3. Female	14	15
4.	Socioeconomic Status	Middle class	23	20	0.22
		5. Lower class	2	5
6.	Marital Status	Married	24	24	1
		7. Unmarried	1	1
8.	Education status	Primary	9	11	0.25
		9. High school	2	6
		10. Graduate	9	6
		11. Uneducated	5	2
12.	Prakirti	Vata Kapha	6	4	0.63
		13. Vata Pitta	8	11
		14. Pitta Kapha	11	10
15.	Family history of insomnia and psychiatric illness		1	1	1
16.	Duration of illness (years)		1.91 ± 3.08	1.20 ± 1.01	0.283
17.	Study completed		25	24	–

Table 2.

Effect of Intervention on clinical outcomes

S.No	Clinical Variables	Groups	Baseline	15th day	30th day	P (BL-15th day)	P (15th–30th day)	P(BL-30th day)	P value	Effect Size (0–30 days)
1.	ISI	TC	17.58 ± 2.04	15 ± 2.37	12.75 ± 3.92	<0.001	0.004	<0.001	0.01	1.84
		MG	18.70 ± 2.03	14.25 ± 2.36	8.16 ± 1.83	<0.001	<0.001	<0.001
2	PSQI	TC	13.41 ± 1.97	10.37 ± 2.44	8.08 ± 1.81	<0.001	<0.001	<0.001	0.97	0.33
		MG	13.75 ± 1.64	10.45 ± 2.08	7.70 ± 1.33	<0.001	<0.001	<0.001
3	ESS	TC	12.16 ± 3.23	12.12 ± 4.86	10.70 ± 4.14	1	0.08	0.38	0.01	0.78
		MG	12.04 ± 2.42	9.37 ± 2.53	7.20 ± 2.41	<0.001	<0.001	<0.001
4	DASS- Total	TC	46.16 ± 12.66	32.70 ± 7.01	26.41 ± 8.29	0.001	<0.001	<0.001	0.32	0.06
		MG	43.37 ± 10.78	33.33 ± 10.90	24.45 ± 10.78	0.02	<0.001	<0.001
5	DASS-Anxiety	TC	17.1 ± 4.27	11.50 ± 3.26	9.6 ± 3.85	<0.001	0.03	<0.001	0.40	0.15
		MG	14.7 ± 6.0	11.08 ± 6.06	8.50 ± 4.75	0.18	<0.001	0.001
6.	DASS- Depression	TC	14.55 ± 3.67	10.80 ± 2.5	8.45 ± 2.74	0.004	0.01	<0.001	0.16	0.16
		MG	12.25 ± 5.49	10 ± 5.01	7.40 ± 3.97	0.4	0.002	0.01
7	DASS- Stress	TC	15.45 ± 4.26	11.80 ± 4.23	9.35 ± 4.08	0.01	0.006	0.001	0.12	0.05
		MG	13.45 ± 5.20	10.1 ± 4.44	7.30 ± 5.19	0.02	<0.001	0.002

Insomnia severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness scale (ESS), Depression Anxiety and Stress Scale (DASS). Values are expressed in mean and standard deviation

Table 4.

Effect of Intervention on BMI, Blood pressure and Blood parameters.

S.No	Clinical Variables	Groups	Baseline	30th day	P(BL–30th day)	P value	Effect Size (0–30days)
1.	Weight (kg)	TC	66.96 ± 7.27	67.68 ± 7.13	0.002	0.38	0.24
		MG	61.56 ± 6.84	60.12 ± 14.27	0.5
2	BMI	TC	24.40 ± 2.32	24.64 ± 2.21	0.004	0.40	0.24
		MG	22.62 ± 1.95	22.09 ± 5	0.56
3	BP-Systolic (mm Hg)	TC	122.88 ± 7.89	125.44 ± 14.47	0.43	0.05	0.56
		MG	129.60 ± 11.59	125.20 ± 11.67	0.01
4	BP-Diastolic (mm Hg)	TC	81.76 ± 6.95	82.32 ± 5.55	0.75	0.35	0.27
		MG	84.08 ± 7.03	82.56 ± 4.41	0.26
5	Hb (g/dl)	TC	12.14 ± 3.87	12.08 ± 3.79	0.73	0.37	0.25
		MG	12.22 ± 2.90	12.75 ± 1.22	0.32
6.	Sr.Creatinine (mg/dl)	TC	0.90 ± 0.29	0.88 ± 0.34	0.68	0.74	0.12
		MG	0.97 ± 0.31	0.96 ± 0.25	0.93
7	Total Bilirubin (mg/dl)	TC	0.64 ± 0.92	0.90 ± 1.57	0.18	0.21	0.12
		MG	0.46 ± 0.13	0.48 ± 0.17	0.50
8	Total Bilirubin (mg/dl)-Direct	TC	0.10 ± 0.08	0.1 ± 0.04	0.64	0.38	0
		MG	0.09 ± 0.02	0.1 ± 0.03	0.16
9	AST (U/L)	TC	24.04 ± 9.21	23.76 ± 8.70	0.69	0.64	0.13
		MG	27 ± 7.91	26.08 ± 7.47	0.45
10	ALT (U/L)	TC	23.24 ± 9.24	22.28 ± 8.64	0.40	0.40	0.25
		MG	22 ± 7.36	22.45 ± 7.37	0.72
11.	Sr Protein (g/dl)	TC	6.23 ± 1.89	6.42 ± 1.96	0.002	0.26	0.45
		MG	6.51 ± 1.40	6.62 ± 1.44	0.06
12	Sr Albumin (g/dl)	TC	3.25 ± 1.02	3.41 ± 1.05	0.009	0.71	0.02
		MG	3.42 ± 0.77	3.67 ± 0.85	0.001
13	A: G RATIO	TC	1 ± 0.33	1.05 ± 0.34	0.14	0.26	0.31
		MG.	0.97 ± 0.25	1.58 ± 2.44	0.23
14	Alkaline Phosphatase (U/L)	TC	152.12 ± 52.63	155.92 ± 54.11	0.31	0.62	0.14
		MG	148.54 ± 37.86	155.95 ± 47.07	0.25

Values are expressed in mean and standard deviation.

3.2. Primary outcome

The efficacy of both the interventions on ISI showed significant difference (p = 0.01). Both the groups showed significant improvement at all the time points included in the study. Effect size was large (1.84) favouring improvement in MG group (Table 2)

3.3. Secondary outcome

ESS showed significant difference on noting the between group comparison (p = 0.01). Assessment amidst group, showed improvement only in MG group and were in all the time points. Effect size was large (0.78) favouring the improvements in MG group. Other parameters like PSQI, DASS-Total, DASS-Anxiety, DASS-Depression, DASS-Stress were comparable between groups. Within group assessments showed significant improvement in all these parameters in both the groups. Effect size was observed to be between low to medium.

Effect of interventions on Sleep diary parameters showed, significant difference in between group comparison in parameters like number of awakenings (p = 0.03) and total sleep time (p = 0.002). Significant improvements were observed in MG group. Other sleep diary parameters like frequency of waking up tired, number of naps, longest nap, time to sleep and actual sleep were comparable in between group assessments. Within group assessments showed significant improvement in both the groups amongst all the sleep diary parameters. Effect sizes were from low to medium.

Changes in other clinical assessments like weight, BMI, Systolic and diastolic blood pressure were comparable between groups. Blood assessment parameters like Haemoglobin, Serum creatinine, Liver function tests like total protein, globulin, albumin, albumin: globulin (AG) ratio, total and direct bilirubin, aspartate aminotransferase, alanine transaminase, alkaline phosphatase were comparable between groups. Serum albumin improved in both the groups but reached normal ranges in MG group only. All the blood parameters except serum albumin were in normal ranges in both pre and post assessments in both the groups (Table 2, Table 3, Table 4).

Table 3.

Effect of Intervention on Sleep Diary variables.

S.No	Clinical Variables	Groups	Baseline	15th day	30th day	P (BL-15th day)	P (15th–30th day)	P(BL-30th day)	P value	Effect Size (0–30 days)
1.	Frequency of waking up Tired (%)	TC	80.65 ± 28.38	47.12 ± 34.34	10.36 ± 10.27	<0.001	<0.001	<0.001	0.36	0.19
		MG	77.47 ± 34.12	53.16 ± 27.73	21.75 ± 27.77	0.001	0.004	<0.001
2	Number of Naps	TC	1.27 ± 1.19	0.80 ± 0.67	0.37 ± 0.47	0.06	0.004	<0.001	0.50	0.07
		MG	1.36 ± 1.19	1.07 ± 0.89	0.40 ± 0.44	0.95	0.001	0.001
3	Longest Nap (mins)	TC	16.04 ± 17.24	11.88 ± 12.17	6.92 ± 9.70	0.14	0.01	0.01	0.44	0.02
		MG	12.78 ± 11.30	10.01 ± 8.76	4.43 ± 6.10	0.19	0.02	0.006
4	Time to sleep (mins)	TC	47.34 ± 20.98	38.03 ± 20.96	22.45 ± 14.28	0.009	<0.001	<0.001	0.46	0.48
		MG	40.65 ± 18.70	34.65 ± 16.95	23.46 ± 6.88	0.02	0.002	<0.001
5	Number of Awakenings	TC	1.26 ± 0.66	0.94 ± 0.58	0.46 ± 0.57	0.10	0.002	0.001	0.03	0.24
		MG.	1.73 ± 0.85	1.36 ± 0.75	0.62 ± 0.52	0.002	<0.001	<0.001
6	Actual Sleep (mins)	TC	258.33 ± 83.80	330.83 ± 67.49	380.62 ± 66.04	<0.001	0.003	<0.001	0.12	0.10
		MG.	235.41 ± 60.28	300.41 ± 54.17	362.08 ± 55.08	<0.001	<0.001	<0.001
7	Total sleep (mins)	TC	370.33 ± 85.57	432.70 ± 63.02	505.04 ± 81.60	<0.001	0.001	<0.001	0.002	0.22
		MG	323.08 ± 40.76	376.5 ± 45.27	473.70 ± 42.67	<0.001	<0.001	<0.001

Values are expressed in mean and standard deviation.

4. Discussion

The study demonstrated that Mamsyadi Ghana Capsule is effective in management of Insomnia disorder. Improvements were better in parameters like ISI, ESS, Total sleep time, and number of awakenings when compared with Tagara churna. Both the interventions were comparable in other parameters like PSQI, DASS-Total, DASS-Anxiety, DASS-Depression, DASS-Stress, sleep diary parameters (Frequency of waking up tired, number of naps, longest nap, time to sleep and actual sleep) Interventions of both the groups showed significant improvement in all these parameters. Effects of interventions were comparable in parameters like haemoglobin, serum creatinine and liver function tests. No adverse effects were observed in any of the interventions. Both interventions showed considerable safety profiles.

Mean age of the patients was 51.6 years. Majority of patients included were female, belonged to middle socioeconomic status, were primary school educated, married, belonged to overweight category, mean duration of illness was 1.58 years. Insomnia Severity index scores were in moderate severity range at base line and reduced to subthreshold range with both the interventions. ISI is the better assessment tool to evaluate sleep and is sensitive to treatment response in Insomnia [39]. PSQI ranges were in poor sleep quality ranges both before and after both the interventions. ESS showed patients had mild excessive daytime sleepiness and reduced to higher normal day time sleepiness in both the groups. DASS scales showed that patients had severe anxiety and got reduced to mild anxiety, moderate depression reduced to normal levels, stress reduced from mild to normal ranges. Sleep diary parameters showed frequency of waking up tired was reduced by more than 56%, time to sleep reduced almost to normal ranges, actual and total sleep time increased to normal ranges with both the interventions.

Mamsyadi Ghana Capsule (contains three drugs like Jatamamsi (Nardostachys jatamansi DC.), Ashwagandha (Withania somnifera (L) Dunal) and Parsika Yavani (Hyoscyamus niger Linn.) (Supplementary data, table 5). According to Ayurveda, Jatamamsi possesses the properties like nidrajanaka (sleep promoting), sanjnasthapaka (re-establishes the conscious in conscious deranged states), medhya (nootropic), vedanasthapaka (analgesic), hridaya niyamaka (cardiotropic)and balavardhaka (strength promoting) [40]. Ashwagandha is balakaraka (strength promoting) and rasayana (rejuvination). Parasika Yavani acts as swapajanaka (sleep inducing) and vedanahara (analgesic). These effects helps to promote and restore the sleep. Acute and subchronic administration of an alcoholic extract of Nardostachys jatamansi roots showed increase in GABA and taurine [41]. Studies on Withania somniferra in sleep disturbed states showed sleep promoting effect through the involvement of GABAergic mechanism [42]. Tagara (Valeriana wallichi DC) churna (Supplementary data, table 6) had Tagara only, Valeriana wallichi root extracts had positive effects on sleep and decrease in wake time after sleep onset [43]. Root extracts of Valeriana wallichion on rats showed dose dependant decrease in sleep latency and increase in non-rapid eye movement (NREM) sleep, duration of sleep, slow wave activity in NREM. In frontal cortex and brain stem, decrease in norepinephrine and serotonin were observed [44]. Tagara churna has showed better effect compared to Jatamamsi churna in patients of primary insomnia [24]. It improved duration of sleep, decreased duration of time to sleep, disturbances in sleep and disturbance in routine works were also decreased.

Other studies have also explored effect of Complementary and Alternative therapies in Insomnia. A Poly herbal compound (NSF-3) has shown effect comparable to Zolpidem in primary insomnia [29]. Shirodhara (Ayurveda procedure of dripping of medicaments over forehead) with warm milk [45], Insomrid tablet and Shirodhara with buffalo milk [46] have shown beneficial effect in insomnia. A study compared Tagaradi churna (compound formulation) and Mamsyadi kwatha in primary insomnia and showed to have similar effect [47].

Study strengths were that it is a randomized clinical trial, assessment done considering various clinical parameters of sleep, sleep severity, sleep qualitative and quantitative assessments, psychological components (anxiety, depression and stress). Limitations of the study included lack of standard control like hypnotic agents. Considering the objective sleep parameters like polysomnography or Actigraph will give better insights. Assessments of hormones can help in better understanding of the drug action.

5. Conclusion

Study showed that Mamsyadi ghana vati is better than Tagaradi churna in management of Insomnia disorder. Mamsyadi ghana vati was better in ISI, ESS and total sleep duration. The qualitative aspects of sleep like waking up tired was improved through both the interventions. Quantitative aspects of sleep like total sleep duration, actual sleep duration, number of naps, longest nap, number of awakenings were also seen to be improved with both the drugs. Both the interventions decreased severity of insomnia, daytime sleepiness, antistress, anxiolytic, antidepressant activity. Both the drugs showed a better safety profile as there were no adverse effects reported and no alteration in the normal creatinine and liver function tests.

Sources of funding

None.

Author contributions

NK- Methodology, Supervision, Data curation, Writing - Reviewing and Editing. BRT-Conceptualization, Methodology, Writing - Original draft preparation, Writing - Reviewing and Editing, Statistical analysis. MM-Visualization, Data collection, Writing - Reviewing and Editing.

Declaration of generative AI in scientific writing

None used.

Conflict of interest

None.

Appendix A. Supplementary data

The following are the Supplementary data to this article: