| CTRI Number |
CTRI/2024/12/077617 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & efficacy of Zandu Chyawanprash in general debility & weak immunity |
|
Scientific Title of Study
|
Evaluation of the safety & efficacy of Zandu Chyawanprash debility & symptoms associated with weak immunity |
| 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 Radha Ballabh Sati |
| Designation |
Professor & Campus Director |
| Affiliation |
Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 |
| Address |
Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand
Ayurved University, Main campus, Station Road, Harrawala
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8077747461 |
| Fax |
|
| Email |
drsatirb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Radha Ballabh Sati |
| Designation |
Professor & Campus Director |
| Affiliation |
Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 |
| Address |
Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand
Ayurved University, Main campus, Station Road, Harrawala
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8077747461 |
| Fax |
|
| Email |
drsatirb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Radha Ballabh Sati |
| Designation |
Professor & Campus Director |
| Affiliation |
Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 |
| Address |
Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand
Ayurved University, Main campus, Station Road, Harrawala
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8077747461 |
| Fax |
|
| Email |
drsatirb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emami Limited 8, Bentick Street, 10th Floor, Taher Mansion, Kolkata 700001, India |
|
|
Primary Sponsor
|
| Name |
Emami Ltd |
| Address |
Emami Limited 8, Bentick Street, 10th Floor, Taher Mansion, Kolkata
700001, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr R B Sati |
Uttarakhand Ayurved University- Main Campus Hospital |
Room no. 01,
Department of
Kayachikitsa OPD &
Room no.11,
Department of Rog
Nidan OPD, Uttarakhand Ayurved
University - Main Campus Hospital, Station
Road, Harrawala,
Dehradun
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL |
8077747461
drsatirb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee main Campus Uttarakhand Ayurved University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
weak immunity and general debility |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chyavanprash, Reference: Ayurved Sar Sangraha, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: luke warm milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subject having any three symptoms among Kasa (Cough), Svarabheda (Hoarseness of voice), Agnimandya (Digestive impairment), Smritidaurbalya (Cognitive issues), Daurbaly (Weak strength, stamina & low energy), Kshin Anamaya (Weak immunity – Frequent illness such as common cold, body ache), Apraharsh (decreased vigour)
Age- 18 years- 65 Years of either sex
Co-operative and fully conscious
|
|
| ExclusionCriteria |
| Details |
Diabetes mellitus, Severe bronchial Asthma /COPD, Any symptomatic cardiac disease, Chronic debilitating conditions like hepatic/ renal insufficiency Carcinogenic condition (Confirmed through history/clinical examination), Any acute illness/ serious illness, Fever/ delirium, hypertension, Known hypersensitivity or allergy to one or more of the herbal ingredients, Recent (less than 1 month) participation in a clinical trial, Recent (less than 1 month) use of any Herbal/Ayurvedic drugs, Other debilitating neurological or psychiatric disorders, Any condition likely to hinder the compliance with the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kasa - Cough symptom score
Agnimandya - Severity of the symptoms of indigestion on the basis of Likert scale
Smritidaurbalya – Verbal recall
Daurbalyata - Visual Analouge Scale score
Kshin Anamay (Weak immunity) – History of frequent illness
Stress & Anxiety – Hamilton anxiety rating scale
|
Day 0, Day 30, Day 60, Day 75 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin, TLC, DLC, ESR, SGPT, SGOT, Urea, Creatinine, FBS |
Day 0, Day 30, Day 60 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
19/12/2024 |
| 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="6"
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
|
Zandu Chyawanprash is a
Classical Ayurvedic medicine and traditional poly-herbal Rasayana formulation marketed in India from decades
for the management of general debility and symptoms associated with weak
immunity. To further
validate these findings, we intend to evaluate the efficacy and safety of this
product using clinical parameters. The study’s objective is to validate the clinical efficacy of Zandu
Chyawanprash on the basis
of scientific
parameters and to evaluate the safety of Zandu Chyawanprash. The study will be conducted at Main Campus, Faculty of Ayurveda, Uttarakhand Ayurved Hospital, Harrawala. |