Table III.
Details of AYUSH trials (n=67) on coronavirus disease 2019 registered in the Clinical Trials Registry - India#
| Serial number | CTRI number | Intervention details | Study design | Blinding | Phase | Sample size | Primary outcome | Sponsor and regulatory status | States and UTs |
|---|---|---|---|---|---|---|---|---|---|
| Ayurveda (n=45) | |||||||||
| Classical (n=21) | |||||||||
| Individual agents (n=11) | |||||||||
| 1 | CTRI/2020/06/025525 | Arm 1: Guduchi Ghana Vati
Arm 2: Nil |
Other | Open label | N/A | 20000 | Incidence rate of COVID-19 infection | IPGTRA, Jamnagar DCGI approval: N/A | GJ (5 sites) |
| 2 | CTRI/2020/05/025488 | Arm 1: Guduchi Ghana Vati
Arm 2: Nil |
Randomized, parallel-group trial | Open label | Phase 2/3 | 12000 | Comparative assessment of incidence of COVID-19 | NIA, Jaipur DCGI approval: N/A | RJ |
| 3 | CTRI/2020/05/025485 | Arm 1: Guduchi Ghana Vati
Arm 2: Standard prophylactic care |
Non-randomized, active controlled trial | Open label | Phase 2/3 | 5000 | Comparative assessment of occurrence of COVID-19 infection | NIIMH (CCRAS), Hyderabad DCGI approval: N/A | TS |
| 4 | CTRI/2020/05/025385 | Arm 1: Guduchi Ghan Vati
Arm 2: Standard prophylactic care |
Non-randomized, multiple-arm trial | N/A | N/A | 40000 | Comparative assessment of occurrence of COVID-19 infection | CCRAS, New Delhi DCGI approval: N/A | WB, PB, TN, KL (2 sites), MH (2 sites), NL, MP, RJ (2 sites), UP, AS, BR (2 sites), KA, HP, GJ (2 sites), AP |
| 5 | CTRI/2020/05/025370 | Arm 1: Guduchi Ghana Vati | Single-arm trial | Open label | N/A | 40 | Clinical cure rate: Time to get a negative status of COVID-19 | Ayurved University, Jodhpur DCGI approval: N/A | RJ (2 sites) |
| 6 | CTRI/2020/05/025213 | Arm 1: Guduchi Ghana Vati | Single-arm trial | N/A | N/A | 1500 | Incidence of COVID-19-positive cases as confirmed by RT-PCR | CCRAS, New Delhi DCGI approval: N/A | HP |
| 7 | CTRI/2020/05/025088 | Arm 1: Guduchi
Arm 2: Standard prophylactic care |
Randomized, parallel-group trial | N/A | Phase 1/2 | 1200 | Comparative assessment of occurrence of COVID-19 infection in healthy volunteers | CCRAS, New Delhi DCGI approval: N/A | AP |
| 8 | CTRI/2020/05/025429 | Arm 1: Ashwagandha + standard prophylactic care Arm 2: Standard prophylactic care |
Non-randomized, active controlled trial | Open label | Phase 2/3 | 5000 | Comparative assessment of occurrence of COVID-19 infection | NIIMH (CCRAS), Hyderabad DCGI approval: N/A | TS |
| 9 | CTRI/2020/05/025332 | Arm 1: Ashwagandha
Arm 2: HCQ |
Randomized, parallel-group, active controlled trial | Open label | Phase 2 | 400 | (i) Proportion of SARS- CoV-2 infection-free participants on completion of study (ii) Proportion of participants contracting COVID-19 during the study period |
Ministry of AYUSH; CSIR, New Delhi DCGI approval: N/A | MH |
| 10 | CTRI/2020/05/025166 | Arm 1: Ashwagandha | Randomized, parallel-group trial | Open label | Phase 2/3 | 1200 | Comparative assessment of occurrence of COVID-19 infection | Ministry of AYUSH, New Delhi DCGI approval: N/A | AP |
| 11 | CTRI/2020/05/025093 | Arm 1: Yashtimadhu | Other | N/A | Phase 2/3 | 1200 | Comparative assessment of occurrence of COVID-19 infection | Ministry of AYUSH, New Delhi DCGI approval: N/A | AP |
| Combination interventions (n=10) | |||||||||
| 12 | CTRI/2020/05/025171 | Arm 1: Guduchi Ghana Vati
2.Anu taila 3.Rock salt and turmeric 4. Ayush preventive guidelines Arm 2: Standard prophylactic care |
Randomized, parallel-group trial | Open label | Phase 2 | 50000 | Improvement in bala of an individual Immuno-stimulation leading to non-development of symptoms of COVID-19 in risk population exposed to infected individuals (Bala will be assessed by using specialized proforma including dasvidhapareeksha and other questionnaires which will reveal the physical and mental health of an individual) |
AIIA, New Delhi DCGI approval: N/A | DL |
| 13 | CTRI/2020/05/025069 | Arm 1: Guduchi Ghana Vati (Sanshamani Vati) or Sudarshana Ghanavati or Ashwagandha | Single-arm trial | Open label | Phase 3/4 | 1324 | Incidence of COVID-19- positive cases (as confirmed by RT-PCR) | CCRAS, New Delhi DCGI approval: N/A | DL (3 sites) |
| 14 | CTRI/2020/05/025482 | Arm 1: Curcumin with black pepper Arm 2: Standard treatment |
Randomized, parallel-group trial | Investigator blinded | N/A | 50 | COVID-19 test and acute phase reactants such as D-dimer, CRP, LDH, CBC, ferritin, troponin, cardiac myoglobin, PT INR and appearance of respiratory symptoms | Siddhivinayak Pain Relief Center, Pune DCGI approval: N/A | MH |
| 15 | CTRI/2020/06/025637 | Arm 1: Piper betel with the combination of swarnabhasma (herbomineral combination) | Cluster randomized trial | Participant and investigator blinded | N/A | 10 | Complete blood picture, serum ferritin, C-reactive protein, LDH, troponin, nucleic acid amplification test and RT-PCR | ABVGMC, Vidisha DCGI approval: N/A | MP |
| 16 | CTRI/2020/05/025341* | Arm 1: Kiratiktadi Kwath; Ashwagandha churna; Yoga exercises; immunobooster Ayush Kwath
Arm 2: Standard treatment |
Randomized, parallel-group trial | N/A | N/A | 30 | Efficacy in the management of mild and asymptomatic cases of COVID-19 patients | GS Ayurveda Medical College and Hospital, Ghaziabad DCGI approval: N/A | UP |
| 17 | CTRI/2020/04/024731* | Arm 1: Samshamani Vati, Sudarshan Ghana Vati, Khadiradi Vati, Murrchhita Tila Taila (for Nasya, Arsenic Album 30 | Single-arm trial | Open label | Phase 3 | 50 | Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) | Parul Institute of Ayurved, Vadodara DCGI approval: N/A | GJ |
| 18 | CTRI/2020/04/024882 | Arm 1: Kashaya (decoction) of Tinospora cordifolia stem Piper longum fruit, and standard treatment Arm 2: Standard treatment |
Non-randomized, active controlled trial | N/A | Phase 3 | 60 | 1. Percentage of patients progressing to serious/critical stage of disease 2. Progress of disease as per clinical severity score (COCSS) 3. Number of days of treatment, hospitalization, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity 4. Number of days taken to test negative for COVID, total days to discharge from hospital 5. Profiling according to tridosha 6. Defining the disease according to Ayurveda |
Ministry Of AYUSH, New Delhi DCGI approval: N/A | HR |
| 19 | CTRI/2020/05/025178 | Arm 1: Tab Samshamani Vati; Herbal tea; application of Anu taila; Haridra khanda
Arm 2: Standard prophylactic care |
Randomized, parallel-group trial | Open label | Phase 2 | 140 | Improvement in bala of an individual Bala will be assessed by using specialised proforma including dashavidhapareeksha and other questionnaires which will reveal the physical and mental health of an individual | AIIA, New Delhi DCGI approval: N/A | DL |
| 20 | CTRI/2020/05/025276 | Arm 1: Sanshamani Vati (Tinospora cordifolia); Nagaradi kwath (decoction of Zingiber officinale, Terminalia chebula and Tinospora cordifolia); Amalaki Churna (powder of Phyllanthus emblica); Golden Milk (milk with Curcuma longa) | Single-arm trial | N/A | Phase 3 | 50 | Time taken and number of patients progressing from asymptomatic to symptomatic condition | Ch Brahm Prakash Ayurved Charak Sansthan, New Delhi DCGI approval: N/A | DL |
| 21 | CTRI/2020/05/025398* | Arm 1: Kiratiktadi Kwath (Astadashang Kwath) Sharangdhar Samhita -kwath prakaran; Ashwgandhachurna with milk; Yoga | Single-arm trial | N/A | N/A | 30 | 1. Efficacy in boosting Vyadhikshamatwa and prevention against communicable diseases. 2. Will help in overcoming the anxiety level and stress of HCQs |
GS Ayurveda Medical College and Hospital, Hapur DCGI approval: N/A | UP |
| Patented products (n=24) | |||||||||
| 22 | CTRI/2020/06/025557 | Arm 1: AYUSH-64 as add on to standard treatment Arm 2: Yashtimadhu as add on to standard treatment Arm 3. Sanshamani Vati Plus; as add-on standard treatment Arm 4: Standard treatment |
Randomized, parallel-group, active controlled trial | Open label | Phase 2 | 420 | 1. Mean time (days) for clinical recovery 2. Proportion of patients showing clinical recovery |
Ministry of AYUSH, New Delhi DCGI approval: N/A | MH |
| Patented products (n=24) | |||||||||
| 23 | CTRI/2020/05/025156 | Arm 1: AYUSH-64 Arm 2: Standard treatment |
Randomized, parallel-group, active controlled trial | Open label | Phase 3/4 | 60 | Clinical cure rate: Time to negative conversion of SARS-CoV-2 | CCRAS, New Delhi DCGI approval: N/A | MH |
| 24 | CTRI/2020/05/025335 | Arm 1: AYUSH-64 | Single-arm trial | N/A | Phase 3 | 40 | 1. Mean time (days) for clinical recovery as per defined clinical recovery criteria 2. Number of patients showing ‘clinical recovery’ |
CCRAS, New Delhi DCGI approval: N/A | DL |
| 25 | CTRI/2020/05/025338 | Arm 1: AYUSH-64 | Single-arm trial | N/A | Phase 2/3 | 40 | 1. Mean time (days) for clinical recovery as per defined clinical recovery criteria 2. Number of patients showing ‘clinical recovery’ |
CCRAS, New Delhi DCGI approval: N/A | DL |
| 26 | CTRI/2020/05/025214 | Arm 1: AYUSH-64 Arm 2: Standard treatment |
Randomized, parallel-group, active controlled trial | Open label | Phase 2/3 | 80 | 1. Mean time (days) for clinical recovery (day of randomization to the day of clinical recovery) 2. Proportion of patients showing ‘clinical recovery’ |
CCRAS, New Delhi DCGI approval: N/A |
CH |
| 27 | CTRI/2020/05/025484 | Arm 1: Chyawanprash Arm 2: Standard prophylactic care |
Non-randomized, active controlled trial | Open label | Phase 2/3 | 5000 | Comparative assessment of occurrence of COVID-19 infection | NIIMH (CCRAS), Hyderabad DCGI approval: N/A | TS |
| 28 | CTRI/2020/05/025425 | Arm 1: Chyawanprash | Single-arm trial | N/A | Phase 3/4 | 50 | Percentage of participants with SARS CoV-2 positivity as estimated by RT-PCR of nasopharyngeal swab | CCRAS, New Delhi DCGI approval: N/A | DL |
| 29 | CTRI/2020/05/024981 | Arm 1: Chyawanprash with milk Arm 2: Milk |
Randomized, parallel-group trial | Open label | N/A | 600 | 1. Comparative assessment of incidence of COVID-19 2. Comparative assessment of incidence of other non-COVID-19 infections |
Dabur India Ltd, Ghaziabad DCGI approval: N/A | GJ (2 sites), MH (2 sites), RJ |
| 30 | CTRI/2020/05/025275 | Arm 1: Chyawanprash Arm 2: Standard prophylactic care |
Randomized, parallel-group trial | N/A | Phase 3 | 200 | Percentage of participants with SARS CoV-2 positivity as estimated by RT-PCR | CCRAS, New Delhi DCGI approval: N/A |
DL |
| 31 | CTRI/2020/06/025592 | Arm 1: Shakti drops; turmeric plus; Tulsi arka | Single-arm trial | Open label | Phase 3/4 | 50 | Recovery in the signs and symptoms as fever and respiratory distress | Sri Sri Tattva, Bangalore DCGI approval: N/A | KA |
| 32 | CTRI/2020/06/025590 | Arm 1: Astha-15 capsule and standard treatment Arm 2: Placebo and standard treatment |
Randomized, parallel-group, placebo-controlled trial | Participant, investigator and outcome assessor blinded | Phase 3 | 120 | 1. Changes in scores of the St. George Respiratory Questionnaire from baseline to EOT visit 2. Changes in scores of the Leicester Cough Questionnaire from baseline to EOT visit |
Dalmia Centre for Research and Development, Noida DCGI approval: N/A | AP, RJ, DL, MH |
| 33 | CTRI/2020/05/025483 | Arm 1: Clevira tablet Arm 2: Standard treatment |
Randomized, parallel-group trial | N/A | Phase 3/4 | 100 | 1. Time taken for clinical recovery, which is defined as: (i) normalization of pyrexia and body pain; (ii) respiratory rate <24/minute; (iii) SpO2 rate >94%; (iv) relief from cough and maintenance of above for > 72 h 2. Proportion of patients with swabs negative for COVID-19 in RT-PCR at day 5, 10 and 15 |
Apex Laboratories Pvt Ltd, Chennai DCGI approval: N/A | TN |
| 34 | CTRI/2020/05/025334 | Arm 1: SUVED + Reimmungen | Single-arm trial | N/A | Phase 2 | 30 | Prevention of onset or complications of COVID infection | Health Solutions, Pune DCGI approval: N/A | MH |
| 35 | CTRI/2020/05/025343 | Arm 1: SUVED + Reimmungen | Single-arm trial | N/A | Phase 2/3 | 30 | Mortality | Health Solutions, Pune DCGI approval: N/A | MH |
| 36 | CTRI/2020/05/025340 | Arm 1: ShatPlus and standard treatment Arm 2: Standard treatment |
Randomized, parallel-group trial | Open label | Phase 1/2 | 60 | 1. Number of days for negative PCR confirmatory test from nasopharyngeal swab for SARS-CoV-2 2. Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG |
BVG Life Sciences Ltd, Pune DCGI approval: N/A | MH |
| 37 | CTRI/2020/05/025161 | Arm 1: Aayudh advance bacteria, viruses Arm 2: Standard treatment |
Randomized, parallel-group, active controlled trial | Open label | Phase 2 | 120 | 1. Rate of recovery 2. Symptom resolution: fever 3. Symptom resolution: cough 4. Symptom resolution: shortness of breath |
Shukla Ashar Impex Pvt Ltd, Rajkot DCGI approval: N/A | GJ |
| 38 | CTRI/2020/04/024883 | Arm 1: ZingiVir H Arm 2: N/A |
Other | Outcome assessor blinded | Phase 4 | 112 | The odds of ratio for improvement on a 7-point ordinal scale on day 15 Each day, the worst score from the previous day will be recorded | Pankajakasthuri Herbal Research Foundation, Thiruvananthapuram DCGI approval: N/A | KA (2 sites), MH |
| 39 | CTRI/2020/05/024967 | Arm 1: MyVir tablets Arm 2: Standard treatment |
Single-arm trial | N/A | Post marketing surveillance | 30 | Improvement in patients who are assessed daily for symptoms which include cough, fever with or without chills and difficulty in breathing for the period they are in quarantine | Mi Lab LifeSciences Pvt Ltd, Bengaluru, DCGI approval: N/A | KA |
| 40 | CTRI/2020/06/025527 | Arm 1: Amrta Karuna syrup Arm 2: Standard treatment |
Non-randomized, active controlled trial | N/A | Post marketing surveillance | 30 | 1. Improvement in patients who are assessed daily for symptoms which include cough, fever with or without chills and difficulty in breathing | Vopec Pharmaceuticals Pvt Ltd, Chennai DCGI approval: N/A | KA |
| 41 | CTRI/2020/05/025326 | Arm 1: Tab Pinak | Single-arm trial | N/A | Phase 2 | 30 | Early recovery and reduced mortality | Shree Bharadi Ayurvedic, Maharashtra DCGI approval: N/A | MH |
| 42 | CTRI/2020/05/025273 | Arm 1: Tablet pure Ashwagandha 500 mg; Pure Giloy extract; tablet pure tulsi extract; Anu Taila; Swasari Ras
Arm 2: Placebo therapy |
Randomized, parallel-group, placebo- controlled trial | NIL | N/A | 120 | Virological clearance as measured by RT-PCR of nasopharyngeal swab | Patanjali Research Institute, Haridwar; NIMS, Jaipur DCGI approval: N/A | RJ |
| 43 | CTRI/2020/05/025222 | Arm 1: AOIM - Z Tablet | Single-arm trial | N/A | Phase 4 | 275 | Prevention of incidence of COVID-19 infection | Shree Dhootapapeshwar Limited, Mumbai DCGI approval: N/A | MH |
| 44 | CTRI/2020/05/025434 | Arm 1: Zingivir-H | Randomized, parallel-group, placebo- controlled trial | Outcome assessor blinded | Phase 4 | 135 | The odds of ratio for improvement on a 7-point ordinal scale on day 15 and clearance of medically attended lung infection due to RT-PCR confirmed COVID-19 infection | Pankajakasthuri Herbal Research Foundation, Thiruvananthapuram DCGI approval: N/A | KA (2 sites), MH |
| 45 | CTRI/2020/06/025556 | Arm 1: Virulina Arm 2: Standard treatment |
Randomized, parallel-group, placebo- controlled trial | Participant and investigator blinded | N/A | 30 | 1. Time to a negative SARS-CoV-2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab. 2. Clinical cure based on clinician’s assessment of symptoms a. Change in positive COVID-19 status on day 8 and day 15 3. Clinical outcomes a. Proportion of patients on WHO progression scale 0 to 10 on day 8 and day 15 |
Natural Solutions, Mumbai DCGI approval: N/A | AP |
| Yoga and Naturopathy (n=3) | |||||||||
| 46 | CTRI/2020/06/025523 | Arm 1: Meditation and breathing exercises and standard treatment Arm 2: Standard treatment |
Randomized, parallel-group trial | N/A | N/A | 84 | Depression, anxiety and stress levels in patients assessed using DASS-21 questionnaire | National Cancer Institute, Jhajjar DCGI approval: N/A DCGI approval: N/A | HR |
| 47 | CTRI/2020/05/025162 | Arm 1: Alternate nostril breathing and guided meditation; (1) Nadi Shodhan Pranayama; (2) Panchakosha meditation Arm 2: The control group will not receive the intervention. |
Randomized, parallel-group trial | N/A | N/A | 200 | PSQI for sleep quality | JIPMER, Puducherry DCGI approval: N/A | PY |
| 48 | CTRI/2020/05/025320* | Arm 1: Yoga and Naturopathy, immune-boosting agents such as ginger Tulsi pepper, Adhimaduram, turmeric, gargling, steam inhalation, Sun bath aromatherapy Arm 2: Standard treatment |
Nonrandomized, active controlled trial | N/A | Phase 3/4 | 658 | Time to progress to next stage of severity i.e., from asymptomatic/uncomplicated/mild pneumonia to moderate/severe stages | Government Yoga And Naturopathy Medical College, Chennai DCGI approval: N/A | TN (4 sites) |
| Unani (n=2) | |||||||||
| 49 | CTRI/2020/06/025650 | Arm 1: Joshanda (decoction) of the following: Behidana (Cydonia oblonga), Unnab (Zizyphus jujube), Sapistan (Cordia myxa) and Khameera Marwareed | Other | Open label | Phase 2 | 4000 | 1. Incidence of COVID-19 cases 2. Improvement in immune status using ISQ |
Ministry of AYUSH, New Delhi DCGI approval: N/A | KA |
| 50 | CTRI/2020/05/025254 | Arm 1: Joshanda (decoction) and Khameera Marwareed
Arm 2: Joshanda (decoction) and Tiryaq e Arba Arm 3: Standard prophylactic care |
Non-randomized, multiple-arm trial | N/A | Phase 3 | 40000 | 1. Incidence of COVID-19 cases 2. Improvement in immune status using ISQ |
CCRUM, New Delhi DCGI approval: N/A | UP, KA, TS, JK, MH, DL |
| Siddha (n=3) | |||||||||
| 51 | CTRI/2020/06/025625 | Arm 1: Kabasura Kudineer and Bramanandhabairavam
Arm 2: Standard treatment |
Other | Open label | Phase 2 | 86 | Proportion of patients confirmed as negative for SARS-CoV-2 in two consecutive throat/nasal swabs (taken 24 h apart) at day 15/day16 | Eminentlabs Business Solutions Pvt Ltd, Chennai DCGI approval: N/A | TN |
| 52 | CTRI/2020/05/025298 | Arm 1: Kabasura Kudineer Nilavembukudineer; Arm 2: Standard prophylactic care |
Non-randomized, active controlled trial | N/A | N/A | 21500 | Occurrence of COVID-19 infection | CCRS, Chennai; Ministry of AYUSH, New Delhi DCGI approval: N/A | TN |
| 53 | CTRI/2020/05/025215 | Arm 1: Kabasura Kudineer
Arm 2: Vitamin C, zinc supplementation |
Randomized, parallel-group trial | Open label | Phase 1/2 | 50 | Reduction in incidence of clinical symptoms of COVID-19, negative conversion of SARS-CoV-2, reduction in viral load of SARS-CoV-2 at the end of treatment and examine the levels immune markers and inflammatory markers | Government Stanley Medical College, Chennai DCGI approval: N/A | TN |
| Homeopathy (n=14) | |||||||||
| 54 | CTRI/2020/06/025530 | Arm 1: Aconite 30 + Arsenic album 30 + Allium cepa 30 + Influenzum 30 + Gelsmium 30 + Eupatorium 30 + Echinacia 0 + Thuja 0 | Non-randomized, active controlled trial | N/A | N/A | 10000 | Number of patients with viral fever/COVID-19 | Cancer Aid Society, Lucknow DCGI approval: N/A | UP |
| 55 | CTRI/2020/05/025491 | Arm 1: Arsenic album 30c Arm 2: Bryonia alba 30c Arm 3: Camphora 1M Arm 4: Coronavirus-related nosodes (30c potency); Arm 5: Matching placebo pills |
Cluster randomized trial | Participant and outcome assessor blinded | Phase 2 | 1000 | Number of patients turning symptomatic | Life Force Foundation Trust, Mumbai DCGI approval: N/A | MH |
| 56 | CTRI/2020/05/025272 | Arm 1: Arsenicum album 30 Arm 2: No. 40 size globules medicated with alcohol 90% v/v is used as placebo |
Cluster randomized trial | Participant and investigator blinded | N/A | 800 | COVID-19 in quarantined persons | Government Homeo Dispensary, Kerala Government Homeo Dispensary, Kerala | KL |
| 57 | CTRI/2020/05/025205 | Arm 1: Arsenicum album 30c Arm 2: No intervention |
Cluster randomized trial | N/A | Phase 2/3 | 33000 | Confirmation of diagnosis for COVID-19 infection based on RT-PCR/end of quarantine period | CCRH, New Delhi DCGI approval: N/A | TN, DL, AP, TS, RJ, WB, KL, MH, UP, GJ |
| 58 | CTRI/2020/05/025049 | Arm 1: Arsenic album 30c | Cluster randomized trial | Open label | Phase 2/3 | 100 | Clinical recovery (COVID-19 negative) or death | Sai Nidan Homeopathy Clinic, Chhattisgarh DCGI approval: N/A | CG |
| 59 | CTRI/2020/05/024986 | Arm 1: Arsenic album 30c | Single-arm trial | N/A | N/A | 10000 | Confirmation of diagnosis for COVID-19 infection/end of quarantine period as per standard protocol | CCRH, New Delhi DCGI approval: N/A | DL |
| 60 | CTRI/2020/05/024969 | Arm 1: Arsenic album 30c (variable dose potency and frequency) and standard treatment Arm 2: Placebo and standard treatment |
Randomized, parallel-group, placebo-controlled trial | Open label | Phase 2/3 | 100 | Clinical outcome in terms of recovery of patient or requirement of life support (ventilator)/death | Naiminath Homoeopathic Medical College Hospital and Research Centre, Agra DCGI approval: N/A | UP |
| 61 | CTRI/2020/04/024926 | Arm 1: Arsenic album, Bryonia alba, Gelsemium, Antimonium tartaricum, Crotalus horridus | Single-arm trial | Participant blinded | Phase 3 | 100 | Clinical recovery (COVID-19 negative) or appearance of symptoms requiring conventional treatment | Naiminath Homoeopathic Medical College Hospital and Research Centre, Agra DCGI approval: N/A | UP |
| 62 | CTRI/2020/04/024905 | Arm 1: Arsenic album, Bryonia alba, Gelsemium, Antimonium tartaricum, Crotalus horridus
Arm 2: Placebo |
Randomized, parallel-group, placebo-controlled trial | Participant blinded | Phase 3 | 100 | Clinical recovery (COVID-19 negative) or death. | Naiminath Homoeopathic Medical College Hospital and Research Centre, Agra DCGI approval: N/A | UP |
| 63 | CTRI/2020/04/024857 | Arm 1: Arsenic album, Camphora, Bryonia alba, Helleborus niger, Justicia adhatoda | Cluster randomized trial | Open label | Phase 1/2 | 100 | Percentage of patient admissions to critical care | Welling Healthcare Private Limited, Mumbai DCGI approval: N/A | MH |
| 64 | CTRI/2020/06/025558 | Arm 1: Bryonia alba 30C Arm 2: Identical placebo |
Randomized, parallel-group, placebo-controlled trial | Participant and investigator blinded | Phase 4 | 300 | Prophylactic effect | Aarogya Homoeopathic Medical College and Hospital, Jaipur; Ministry of AYUSH, New Delhi DCGI approval: N/A | RJ |
| 65 | CTRI/2020/04/024947 | Arm 1: Cadamba 200 | Randomized, parallel-group, active controlled trial | N/A | Phase 3 | 100 | Serologically negative blood test for COVID-19 | PI initiated, Homeo clinic, Gondia-Maharashtra DCGI approval: N/A | MH |
| 66 | CTRI/2020/05/025496 | Arm 1: CNV01 | Single-arm trial | Open label | Phase 1 | 10 | Safety measure in terms of investigations (PCR) blood parameters | Life Force Foundation Trust, Mumbai DCGI approval: N/A | MH |
| 67 | CTRI/2020/04/024925 | Arm 1: Homoeopathic medicine and standard treatment Arm 2: Placebo and standard treatment |
Randomized, parallel-group, placebo-controlled trial | Open label | Phase 2 | 100 | Clinical recovery of patient or requirement of life support (ventilator)/death | Bajaj Auto Ltd, Maharashtra DCGI approval: N/A | MH (2 sites) |
#Registered trials as on June 5, 2020, *Trials with combination therapy (involving more than one system of AYUSH) are mentioned in only one category to avoid duplication. AYUSH includes Ayurveda, Yoga, Unani, Siddha, Homeopathy trials. Table data are as per information provided by trialist. The keyword ‘Standard treatment’ and has been used for uniformity and includes the following category as mentioned by the trialist i.e., standard of care, standard care of treatment and supportive management, standard treatment protocol, local-level standard treatment, best supportive care, treatment guidelines as per MOHFW. The term ‘Standard prophylactic care’ has been used for uniformity which represents the terminologies used by the trialist for standard preventive measures against COVID-19. AAIA, All India Institute of Ayurveda; ABVGMC, Atal Bihari Vajpayee Government Medical College; AYUSH, Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy; COVID-19, coronavirus disease 2019; CCRAS, Central Council for Research in Ayurvedic Sciences; CCRUM, Central Council for Research in Unani Medicine; CCRS, Central Council for Research in Siddha; CCRH, Central Council for Research in Homoeopathy; CSIR, Council of Scientific and Industrial Research; IPGTRA, Institute for Post Graduate Teaching and Research in Ayurveda; JIPMER, Jawaharlal Institute of Postgraduate Medical Education and Research; NIA, National Institute of Ayurveda; NIIMH (CCRAS), National Institute of Indian Medical Heritage (CCRAS); NIMS, National Institute of Medical Sciences Jaipur; PI, Principal investigator; N/A, not applicable; ISQ, immune status questionnaire; PSQI, Pittsburgh Sleep Quality Index; HCQ, healthcare worker; RT-PCR, reverse transcription polymerase chain reaction; DASS-21, depression, anxiety and stress scale - 21items; DCGI, Drugs Controller General of India; CRP, C-reactive protein; LDH, lactate dehydrogenase; CBC, complete blood count; PT INR, prothrombin time international normalized ratio; NK, natural killer. States and Union Territories (UTs): AP: Andhra Pradesh; AR: Arunachal Pradesh; AS: Assam; BR: Bihar; CG: Chhattisgarh; GA: Goa; GJ: Gujarat; HR: Haryana; HP: Himachal Pradesh; JK: Jammu and Kashmir; JH: Jharkhand; KA: Karnataka; KL: Kerala; MP: Madhya Pradesh; MH: Maharashtra; MN: Manipur; ML: Meghalaya; MZ: Mizoram; N: Nagaland; OR: Odisha; PB: Punjab; RJ: Rajasthan; SK: Sikkim; TN: Tamil Nadu; TR: Tripura; UK: Uttarakhand; UP: Uttar Pradesh; WB: West Bengal; TS: Telangana; AN: Andaman and Nicobar Islands; CH: Chandigarh; DH: Dadra and Nagar Haveli; DD: Daman and Diu; DL: Delhi; LD: Lakshadweep; PY: Puducherry