| CTRI Number |
CTRI/2021/02/031547 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
04/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to induce immunity and herd immunity against viruses including covid 19 |
|
Scientific Title of Study
|
Broad Spectrum Antiviral Prophylactic Unani Medicine to Induce Immunity and Herd immunity based on empirical evidence of unani system of medicine
|
| Trial Acronym |
BSAPUM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Mujtaba Ali Hashmi |
| Designation |
Unani Medical Practitioner |
| Affiliation |
Dr. Hashmis Unani Medicine Observation & Research Foundation |
| Address |
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
Dr.Syed Mujtaba ali Hashmi Clinic
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
Hyderabad
TELANGANA
500064
India |
| Phone |
9885828079 |
| Fax |
|
| Email |
dr_s_mujtabaali@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Mujtaba Ali Hashmi |
| Designation |
Unani Medical Practitioner |
| Affiliation |
Dr. Hashmis Unani Medicine Observation & Research Foundation |
| Address |
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
TELANGANA
500064
India |
| Phone |
9885828079 |
| Fax |
|
| Email |
dr_s_mujtabaali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Mujtaba Ali Hashmi |
| Designation |
Unani Medical Practitioner |
| Affiliation |
Dr. Hashmis Unani Medicine Observation & Research Foundation |
| Address |
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad
TELANGANA
500064
India |
| Phone |
9885828079 |
| Fax |
|
| Email |
dr_s_mujtabaali@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Hashmis Unani Medicine Observation and Research
Foundation
19-4-346/2 Kondareddyguda
Kishanbagh Hyd 64 TS |
| Dr. Hashmis Unani Medicine Observation and Research Foundation 19-4-346/2 Kondareddyguda Kishanbagh Hyd 64 TS |
|
|
Primary Sponsor
|
| Name |
Dr Hashmis Unani Medcine Observation Research Foundation |
| Address |
Dr Hashmis Unani Medcine Observation Research Foundation |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Syed Mujtaba Ali Hashmi |
Dr.Syed Mujtaba Ali Hashmi s clinic |
19-4-346/1 kishenbagh
Hyd 64
Hyderabad
TELANGANA |
9885828079
dr_s_mujtabaali@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr Hashmis Unani Medicine Observation and Research Foundation |
Approved |
| Dr Hashmis Unani Medicine Observation and Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All vital including the glycemic levels should be normal.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
extracts of
Aloe vera --------------2mg
Commiphora myrrah-------img
Saffron-----------------1mg
aquas extract of
Rosa Damascena--------20ml |
9Yrs to 14Yrs---2mg tab once a day with 5ml rose water for 60 days
15Yrs to 20Yrs---4mg onca day with 10ml rose water for 60 days
21Yrs to 90Yrs---4mg two time a day with
20ml rose water for 60 days |
| Intervention |
extracts of Aloe vera --------------2mg Commiphora myrrah-------img Saffron-----------------1mg aquas extract of Rosa Damascena--------20ml |
9Yrs to 14Yrs---2mg tab once a day with 5ml rose water for 60 days 15Yrs to 20Yrs---4mg onca day with 10ml rose water for 60 days 21Yrs to 90Yrs---4mg two time a day with 20ml rose water for 60 days |
| Comparator Agent |
not applicable |
not applicaple |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
age group 9 to 80 years male and female with normal vitals and blood sugar |
|
| ExclusionCriteria |
| Details |
below 9 years, between mensuration in females and pregnancy in females |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stress levels willbe reduced, frequency of cold effects will be reduced, tummy troubles (constipation and indigestion issues) will be reduced and feeling of triedness will be reduced |
0 to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stress levels willbe reduced, frequency of cold effects will be reduced, tummy troubles (constipation and indigestion issues) will be reduced and feeling of triedness will be reduced |
0 to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The vaccine for novel Corona Virus is a matter of rigorous research across all the system of medicine in order to save the human life from the epidemic of novel Corona Virus. The concept of Heard Immunity to prevent the spread of novel Corona virus is also a matter of serious study. The literature in Unani system of medicine show the use of Broad Spectrum Antiviral Prophylactic Medicine (BSAPM) to induce immunity and Herd immunity against various types of virus infected diseases. The ancient empirical evidence proves that the herd immunity through administration of BSAPM shown that the pandemic called the “Anthonine Plaque†of 165 to 180 AD (Plaque of Galen) was successfully eradicated. Thus, there is a need to take a scientific study of BSAPM (Unani) to prevent the spread of novel corona virus. This paper deals with BSAPM (Unani) with comparative study of poly-protein strategy and herd immunity concept, the two experiments widely discussed among the scientific community as a measure to prevent the spread of novel corona virus. updates; 20/10/2021. In Analysis of 300 patients in the study found:- a. 9% of those given BSAPM were got infected. b. 0.03% were hospitalized. c. two patients died, one in the age of 74yrs./M, with , HTN.DMT2, IHD. another in the age of 60yrs/M, with HTN, DMT2. IHD. So this may be a safe affordable oral prophylactic antiviral medicine would be a fine advance in the fight against COVID, more over it will give huge benefit to uplift AYUSH (Unani) system of medicine.
|