| CTRI Number |
CTRI/2024/06/069116 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Evaluation of Herbal Health Supplements |
|
Scientific Title of Study
|
Clinical Trial of Herbal Health Supplements |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof PC Chaudhary |
| Designation |
Principal Investigator and Head of department |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan State Ayurvedic College and Hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415864985 |
| Fax |
|
| Email |
drpc.chaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Lecturer |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan State Ayurvedic College and Hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6395683971 |
| Fax |
|
| Email |
shailendra.rawat01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Lecturer |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan State Ayurvedic College and Hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6395683971 |
| Fax |
|
| Email |
shailendra.rawat01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Defense Institute of Bio Energy Research, A Unit of Under Defence
Ministry, Government of India Pincode 263139
|
|
|
Primary Sponsor
|
| Name |
Defence Institute of Bioenergy Research unit of under defence ministry Government of India |
| Address |
Diber A unit of DRDO Pithoragarh Uttarakhand pincode 262540 |
| Type of Sponsor |
Research institution |
|
|
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 |
| PROF PC CHAUDHARY |
State Ayurvedic College and Hospital |
Department of Rog
Nidan OPD No.G116
and other OPD of State
Ayurvedic College and
Hospital Lucknow
Pincode 226003
Lucknow
UTTAR PRADESH |
09415864985
drpc.chaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D839||Common variable immunodeficiency,unspecified. Ayurveda Condition: OJOVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: HERBAL HEALTH SUPPLEMENT (GHRITKUMARI, KALI TULSI, MANDUKPARNI, BRAHMI, KONCH, SUCROSE), Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Immunocompromised patient
2. Age 30years to 70years
3. Chronic disease like diabetes mellitus, bronchial asthma, T.B. etc..
|
|
| ExclusionCriteria |
| Details |
1. Patient are unstable and severely ill.
2. Patient below age 30years and above 70years.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of the trial product |
Before trial and 60th day of trial and 30th day after complete trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pathological evaluation & if any side effects |
Before trial & after two months |
|
|
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)
|
15/07/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The clinical trial of herbal health supplyment formulated by d.i.b.e.r. a unit of d.r.b.d. pithoragarh uttarakhand. Herbal health supplyment contain ghritkumari (13ml), kali tulsi (500mg), mandukparni (250mg), brahmi (250mg), konch (250mg), sucrose (9.750gram) the detail toxicological evaluation of this product has been validated from cdri lucknow. This product was found toxicologically see and freefrom heavy metals. The toxicological studies of this herbal formulation has been carried out at sriram institute new delhi and diber, pithoragarh for acute oral toxicity, sub-acute odral toxicity, sub- chronic toxicity and chronic toxicity. This health supplement is free from heavy metals and found safe for human being. |