Table IV.
Details of miscellaneous trials (n=13) 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 |
|---|---|---|---|---|---|---|---|---|---|
| 1 | CTRI/2020/05/025248 | Arm 1: Brief tele-counselling model for coping with psychological concerns associated with COVID-19 | Non-randomized, multiple-arm trial | N/A | N/A | 128 | Anxiety (assessed as a continuous variable on HADS) | PI initiated, MB Hospital RNT Medical College Udaipur DCGI approval: N/A | RJ |
| 2 | CTRI/2020/05/025492 | Arm 1: Tele-consultation Arm 2: Standard arm with routine follow up visits |
Randomized, parallel-group trial | Open label | N/A | 2978 | Need for emergency room visit or re-hospitalization | JIPMER, Puducherry DCGI approval: N/A |
PY |
| 3 | CTRI/2020/05/025331 | Arm 1: Home-based prehabilitation | Non-randomized, active controlled trial | NIL | N/A | 15 | Change in emotional functioning by DASS-21, physical functioning by change in performance score (Karnofsky Performance Scale) score and change in respiratory functional parameters | AIIMS, New Delhi DCGI approval: N/A |
DL |
| 4 | CTRI/2020/05/024962 | Arm 1: Povidone-iodine gargles and intranasal application Arm 2: Normal saline |
Randomized, parallel-group trial | N/A | N/A | 96 | Comparing the reduction in the progression, transmission of disease assessed by viral load | Win Medicare Pvt Ltd, Vijaywada DCGI approval: N/A |
AP |
| 5 | CTRI/2020/05/024983 | Arm 1: Topical lignocaine lozenges | Single-arm trial | N/A | N/A | 30 | Sensitivity of nasal and throat swabs for RT-PCR of COVID-19 after topical lignocaine use | AIIMS, New Delhi DCGI approval: N/A |
DL |
| 6 | CTRI/2020/04/024776 | Arm 1: Chest X-ray artificial intelligence module Arm 2: CT- scan of thorax AI module Arm 3: Voice sampling AI module Arm 4: Normal individuals’ chest X-ray, CT-scan thorax and voice sampling |
Non-randomized, multiple-arm trial | N/A | N/A | 1650 | Assess sensitivity and specificity of AI module by performing chest X-ray, CT-thorax and voice sampling | PI initiated RNT Medical College, Udaipur DCGI approval: N/A |
RJ (2 sites) |
| 7 | CTRI/2020/05/025071 | Arm 1: Lowest driving pressure-guided PEEP Arm 2: Conventional lung protective ventilation strategy |
Randomized, parallel-group trial | Participant blinded | Phase 3 | 40 | Difference in the area under the curve (adjusted to survival time) for Murray’s lung injury score in the first 4 days | AIIMS, New Delhi DCGI approval: N/A |
DL |
| 8 | CTRI/2020/05/025489 | Arm 1: CMAC video laryngoscope Arm 2: McGrath MAC video laryngoscope |
Randomized, parallel-group trial | Participant and outcome assessor blinded | N/A | 60 | Time to intubation | AIIMS, New Delhi DCGI approval: N/A |
DL |
| 9 | CTRI/2020/06/025522 | Arm 1: Touren non-channelled video laryngoscope Arm 2: King Vision channelled video laryngoscope |
Randomized, cross-over trial | Outcome assessor blinded | N/A | 50 | Time to intubation | AIIMS, New Delhi DCGI approval: N/A | DL |
| 10 | CTRI/2020/06/025589 | Arm 1: COVID barrier box with Ambu King vision video laryngoscope Arm 2: COVID barrier box with Macintosh laryngoscope |
Randomized, parallel-group, active controlled trial | NIL | N/A | 60 | Intubation time | AIIMS, Bhubaneswar DCGI approval: N/A | OR |
| 11 | CTRI/2020/04/024747 | Arm 1: Simulation-based training of ventilatory management of COVID-19 patients | Single-arm trial | Participant and outcome assessor blinded | N/A | 26 | Prepare a module for non-anaesthesiology trainees to handle ventilators in COVID-19 patients | GSL Medical College, Rajahmundry DCGI approval: N/A |
AP |
| 12 | CTRI/2020/05/025490* | Arm 1: Chlopromazine + NBE extract concoction + cholecalciferol + Azadirachta indica bark extract concoction + Arsenicum album + tea + Arm 2: Standard treatment | Randomized parallel-group active controlled trial | Participant and investigator blinded | Phase 2/3 | 110 | Protection from COVID-19 infection | Siddhartha Hospital, Agra DCGI approval: N/A |
UP |
| 13 | CTRI/2020/04/024659 | Arm 1: Shreepad Shree Vallabh formulation | Single-arm trial | N/A | Phase 3 | 30 | Improvement in symptoms of ambulatory patients which include cough, fever with or without chills and difficulty in breathing | SSV Phytopharmaceuticals, Mumbai DCGI approval: N/A |
MH |
#Registered trials as on June 5, 2020, *Combination trials with modern medicine, Ayurveda and homeopathy. Table data are as per information provided by trialist. AIIMS, All India Institute of Medical Sciences; COVID-19, coronavirus disease 2019; JIPMER, Jawaharlal Institute of Postgraduate Medical Education and Research; MB Hospital RNT Medical College, Maharana Bhupal Hospital, Ravindra Nath Tagore Medical College; PI, principal investigator; AI, artificial intelligence; DCGI, Drugs Controller General of India; N/A, not applicable; HADS, hospital anxiety and depression scale; DASS-21, depression, anxiety and stress scale 21 items; RT-PCR, reverse transcription-polymerase chain reaction. 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