| CTRI Number |
CTRI/2020/06/026227 [Registered on: 29/06/2020] 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
|
A Study on Unani regimen
for prevention of high/moderate risk population of COVID 19 |
|
Scientific Title of Study
|
A Study on prophylactic interventions of Unani Medicine on high/moderate risk population of COVID 19 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| CCRUM 04/06/2020/ Version 1.0/ 10/06/20 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Prof Asim Ali Khan |
| Address |
Room No. 523, 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
Modification(s)
|
| Name |
Dr Naheed Parveen |
| Address |
Room No. 507, 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 Contact Person
Public Query
Modification(s)
|
| Name |
Dr Pradeep Kumar |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.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 |
| Prof Asim Ali Khan |
Regional Research Institute of Unani Medicine |
D-11, Abul Fazal Enclave, Jamia Nagar
North
|
01128525715
unanimedicine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Council for Research in Unani Medicine (CCRUM), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Coronavirus as the cause of diseases classified elsewhere |
| Healthy Human Volunteers |
U07.1 COVID 19 |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment being given in quarantine centers in Delhi |
As per Centre/State Govt policy |
| Intervention |
Khameera Marwareed |
5g orally once daily in the morning for 14days |
| Intervention |
Tiryaq-e-Arba |
5gm orally with lukewarm water in the Morning for 14days |
| Intervention |
Unani Joshanda/decoction (Behidana (Cydonia oblonga) 3 gm, Unnab (Zizyphus jujube)
5 in number, Sapistan (Cordia myxa)9 in numbers |
lukewarm decoction once
daily in the Evening for 14days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Population as described as High/ Moderate Risk group
2.Individuals who are from the identified quarantine facility
3.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 clinical history of uncontrolled/ unstable co-morbidities
6.Known Immuno-compromised individuals or those on immune-suppressantdrugs and steroids
7.Subjects having a past history of allergy to any medicine that is a 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
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in immune status using Immune Status Questionnaire (ISQ) |
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2020 |
| 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
Modification(s)
|
Not yet |
|
Brief Summary
|
This study is designed as an Open label, Controlled, randomised, Interventional Clinical trial on high/moderate risk population. 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, Tiryaq-e-Arba 5 gm with lukewarm water in the Morning and Unani Joshanda (Decoction) once daily in the Evening for 14 days. 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 |
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. |
|
