| CTRI Number |
CTRI/2025/01/079552 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Haritaki with Jaggery in Summer Season on Immumity |
|
Scientific Title of Study
|
Immuno-modulatory effect of Ritu Haritaki along with Gud
In healthy individual during the Greeshma Ritu – A Pilot Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Mandal |
| Designation |
PG Scholar Department of Swasthavritta |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 222 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
7011305749 |
| Fax |
|
| Email |
mandalrohit25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Unnikrishnan S |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 232 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
9540265445 |
| Fax |
|
| Email |
drunnikrishnans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Unnikrishnan S |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 232 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan khera dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
9540265445 |
| Fax |
|
| Email |
drunnikrishnans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar , Najafgarh ,South West Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit Mandal |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no 222 , PG Department of Swasthavritta, Institute Block , CBPACS Khera Dadar , Najafgarh , South west Delhi 110073
South West
DELHI |
7011305749
mandalrohit25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immuno Modulation |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: The Ayurvedic pharmacopeia of india, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Gud-), Additional Information: -none | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Roasted wheat flour , Dose 3gm , Duration 2 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy volunteers of either sex in age group 18-30 year
2.Participants willing to give a written consent |
|
| ExclusionCriteria |
| Details |
1. Patients with concurrent Hepatic Dysfunction or Renal Dysfunction ,uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, endocrine disorders, etc.) or known cases of malignancy.
2. Contraindications of haritaki mention in charak Samhita and bhavprakash
3. Women who are planning for conception / pregnant or lactating.
4. Patients suffering from Psychosis/depressive illness
5. History of hypersensitivity to any of the trial drugs or their ingredients.
6. Patient taking participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes from baseline measurements in IgG antibody investigation |
0th , 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in WHO quality of life scale
|
0th , 20th , 40th, 61st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is randomized control trial to compare the effect of Haritaki with Gud in Greeshma Ritu as a immunomodulator and other group with placebo. In one group Haritaki(3gm) with Gud(6gm) will be given daily early morning empty stomach and follow up on 0th , 20th , 40th , 61st day will be done. In another group , placebo (Roasted wheat flour) in 3gm dose is given and follow up done on 0th , 20th , 40th , 61st day . The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome i.e taking Ritu Haritaki in Greeshma Ritu has an immunomodulatory effect and Changes from baseline measurements in IgG antibody investigation will be seen . |