CTRI Number |
CTRI/2020/07/026462 [Registered on: 09/07/2020] Trial Registered Prospectively |
Last Modified On: |
13/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of asymptomatic mild to moderate symptomatic cases. |
Scientific Title of Study
Modification(s)
|
A prospective, interventional, case control study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of the disease in hospitalized SARS-CoV2 tested positive asymptomatic /mild to moderate symptomatic COVID-19 cases, managed as per Govt of India COVID-19 management guidelines, at a COVID-19 management facility |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Asim Ali Khan |
Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West DELHI 110058 India |
Phone |
01128525715 |
Fax |
|
Email |
unanimedicine@gmail.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Usama Akram |
Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West DELHI 110058 India |
Phone |
9540606010 |
Fax |
|
Email |
usamakramdr@gmail.com |
|
Details Contact Person Public Query
|
Name |
Dr Nauman Saleem |
Address |
Department of Ilmul Saidla, A and U Tibbiya college, Karol Bagh
Central DELHI 110005 India |
Phone |
9871505359 |
Fax |
|
Email |
nauman.saleem14@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Unani Medicine Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
|
Primary Sponsor
|
Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Naseem Akhtar |
A K Tibbia College Hospital |
Covid Care Centre, A and U Tibbiya college Hospital, Ajmal Khan Road, Karol Bagh Central |
9354925042
drkhannaseem.akhtarkhan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ayurvedic & Unani Tibbia College & Hospital Institutional Ethics Committee, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Khameera Marvareed |
5 g once daily, Orally for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care |
Comparator Agent |
NIL |
NIL |
Intervention |
Unani Joshanda/ Decoction |
Lukewarm once daily, for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients of either sex aged between 18-65 years
2. Patients who have been tested positive with SARS-CoV2 virus
Asymptomatic Patients
or
Patients with mild symptoms
or
Patients with moderate symptoms with respiratory rate < 30 per minute and oxygen
saturation > 90%
3. Voluntariness to participate in the trial
USCDC classification mild to moderate, severe and critical stages of COVID-19
Stage Features
Asymptomatic No specific clinical symptoms of COVID-19 disease
Mild to Moderate Mild clinical symptoms up to mild pneumonia
Severe Dyspnea, hypoxia, or >50% lung involvement on imaging
Critical Respiratory failure, shock, or multiorgan system dysfunction |
|
ExclusionCriteria |
Details |
The subject must be excluded from participating in the trial if they fulfill anyone of the criteria as
mentioned below:
1. COVID-19 patients with symptoms classified as severe or critical.
2. Suspected COVID-19, not tested positive for COVID-19 by RT-PCR
3. Persons with severe primary respiratory disease or pneumonia
4. Pregnant and lactating women
5. Persons with serious diseases such as Cancer, Heart Disease, Stroke, Disabilities, Mental
illnesses, etc., and who are considered to be excluded from the study as evaluated by the
investigators
6. COVID-19 positive cases participating as subjects in the interventional arm of other
COVID-19 clinical trials |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Time taken to get COVID-19 RT-PCR test negative.
Incidence of patients progressing to next stage with regards to severity |
14 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of subsidence of fever, respiratory and other COVID-19 symptoms |
14days |
|
Target Sample Size
|
Total Sample Size="124" Sample Size from India="124" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
20/07/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet |
Brief Summary
Modification(s)
|
This study is designed as an Open label, Controlled, Non randomised, Interventional Clinical trial in hospitalized SARS-CoV2 tested positive asymptomatic / mild to moderate symptomatic COVID 19 cases at a COVID 19 management facility. After screening, volunteers will be enrolled if they satisfy inclusion and exclusion criteria and will be treated with Khameera Marwareed 5 gm once daily in the morning and Unani Joshanda (Decoction) once daily in the Evening for 14 days, as an add-on therapy along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care. The patients will be assessed clinically at day 0 (baseline), day 7 and day 14 (end of the study). The subjective and objective clinical observations will be recorded in the CRF.
Details of Study drugs:
| | | Unani Joshanda (Decoction) consisting of the following single drugs- Behidana (Cydonia oblonga) 3 gm Unnab (Zizyphus jujube) 5 in number Sapistan (Cordia myxa) 9 in numbers | Preparation of Decoction by boiling these medicines in 250 ml of water, until it remains half and filter it | Use lukewarm decoction once daily in the Evening. |
Composition of Khameera Marwareed: S. No. | Ingredients | Botanical/ English Name | Quantity | 1. | Marwareed | Mytilus margaritiferus | 25g | 2. | Tabasheer | Bambusa arundinacea | 25g | 3. | Sandal safaid | Santalum album | 25g | 4. | Ambar Ash-hab | Ambra grasea | 10g | 5. | Arq e Gulab | Rosa damascena | 1Lit. | 6. | Arq e Bedmushk | Salix caprea | 1Lit. | 7. | Qand safaid | Sugar | 1.5kg |
|