| CTRI Number |
CTRI/2020/05/025254 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To Study effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 |
|
Scientific Title of Study
|
Population based Prospective Study on effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCRUM 05/2020/01 Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 523, 5th Floor
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 of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 507, 5th Floor
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 516, 5th Floor
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
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 = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maqbool Ahmed |
Central Research Institute of Unani Medicine (CRIUM) |
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
6386660524
ddcriumlko@gmail.com |
| Prof Abdul Wadood |
National Institute of Unani Medicine (NRIUM) |
National Institute of Unani Medicine Campus, Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA |
9916608881
crubangalore2000@gmail.com |
| Dr Ahmad Minhajuddin |
National Research Institute of Unani Medicine in Skin Diseases (NRIUMSD) |
A G Colony Road, Opposite ESI Hospital, Erragadda
Hyderabad
TELANGANA |
9177376011
ahmedminhajuddin@yahoo.com |
| Dr Arsheed Iqbal |
Regional Research Institute of Unani Medicine (RRIUM) |
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
9419078302
drarsheediqbal@gmail.com |
| Dr H A Lari |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
9335903933
halariccrum@gmail.com |
| Dr Parvez Khan |
Regional Research Institute of Unani Medicine (RRIUM) |
Post Box 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH |
9411059371
rrium_aligarh@rediffmail.com |
| Dr Shagufta Parveen |
Regional Research Institute of Unani Medicine (RRIUM) |
D-11, Abul Fazal Enclave, Jamia Nagar
South
DELHI |
9810068758
rridelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
| National Institute of Unani Medicine (NRIUM), Bangalore |
Approved |
| National Research Institute of Unani Medicine in Skin Diseases (NRIUMSD), Hyderabad |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
U07.1 COVID-19 |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Unani Joshanda (Decoction)and
Tiryaq-e-Arba |
Unani Joshanda (Decoction) lukewarm once daily in the evening,and Tiryaq e Arba 5g with lukewarm water in the morning for 20 days for 10000 patients. (Test group 1) |
| Intervention |
Unani Joshanda (Decoction)and Khameera Marwareed |
Unani Joshanda (Decoction) lukewarm once daily in the evening and Khameera Marwareed 5g once daily in the morning for 20 days, for 10000 subjects. (Test group 1) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of either sex above 18 and below 68 years
2. Population as described in High/Moderate/Low Risk
3. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case.
4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study |
|
| ExclusionCriteria |
| Details |
1. Persons with severe primary respiratory disease or related complications that may be identified with COVID-19
2. Laboratory confirmed COVID-19 with or without symptoms
3. Pregnant and lactating mothers and those who have a pregnancy plan.
4. Persons with serious critical illness, or severe mental illnesses
5. Individuals with uncontrolled, unstable comorbidities
6. Immunocompromised individuals or those on immunosuppressants and steroids
7. Subjects having a past history of allergy to any medicine that is part of the Unani intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of COVID-19 cases in control as well in interventional group
2.Improvement in immune status using Immune Status Questionnaire (ISQ)
|
20days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40000"
Sample Size from India="40000"
Final Enrollment numbers achieved (Total)= "30931"
Final Enrollment numbers achieved (India)="30931" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2020 |
| Date of Study Completion (India) |
14/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open label, Controlled, Prospective, Interventional, Community-based trial to compare occurrence of COVID 19 infection in clinically stable subjects receiving Unani regimen with those not receiving Unani Regimen in a community having at least 1 confirmed case with standard prophylactic care as control, in the identified containment zone/ quarantine facility. The study will be carried out on a total sample size of 40,000 (forty thousand subjects). Ten thousand in test group 1 ( Unani Joshanda (Decoction)and Khameera Marwareed) and Ten thousand in test group 2 ( Unani Joshanda (Decoction)and Tiryaq e Arba) . And twenty thousand subjects will be enrolled in the control group and will be advised to follow general prophylactic measurements without any medicinal intervention. After screening, subjects will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at day 0 (baseline), day 10 (telephonic follow-up) and day 20 (end of the study). The subjective and objective clinical observations will be recorded in the CRF. This includes Assessment of Immune status Questionnaire (ISQ). The total duration of treatment will be 20days. Test for Covid-19 will be done at any time during the study (if the symptoms develop) as per the guidelines of the central/state or local health authority. Details of study drugs | A. First group will be given: 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 filtered. To be used lukewarm once daily in the Evening. | KhameeraMarwareed | 5 gm once daily in the morning |
B. Second group will be given: 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 filtered. To be used lukewarm once daily in the Evening. | Tiryaq-e-Arba | 5 gm once daily with lukewarm water in the Morning |
| | | 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 | Composition of Tiryaq e Arba: | S. No. | Ingredients | Botanical/ English Name | Quantity | | 1. | Juntiyana | Gentiana lutea | 1part | | 2. | Zarawand taweel | Aristolochia rotunda | 1part | | 3. | Habb-ul-Ghar | Laurus nobilis | 1part | | 4. | Mur Makki | Commiphora myrrha | 1part | | 5. | Asl or Qand safaid | Honey/Sugar | Q.S. |
|