| CTRI Number |
CTRI/2025/06/088198 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate efficacy of Bhringrajadi Churna as Rasayana. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Bhringrajadi churna as Rasayana. |
| 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.Anjana Mishra |
| Designation |
Professor and Head of Department |
| Affiliation |
Rajiv Gandhi govt P.g ayurvedic College & Hospital paprola H.P |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic college and Hospital Paprola Distt Kangra HP 176115
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018101789 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.Sunil Thakur |
| Designation |
Professor |
| Affiliation |
RGGPGAC & H Paprola H.P |
| Address |
Rajiv Gandhi govt Post Graduate Ayurvedic college and Hospital Paprola Distt Kangra HP 176115
Rajiv Gandhi Govt post Graduate Ayurvedic College and Hospital Paprola distt kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Thakur |
| Designation |
PG scholar |
| Affiliation |
RGGPGAC& H Paporla H.P |
| Address |
Rajiv Gandhi govt Post Graduate Ayurvedic college and Hospital Paprola Distt Kangra HP 176115
Rajiv Gandhi Govt post Graduate Ayurvedic College and Hospital Paprola distt kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816252086 |
| Fax |
|
| Email |
pjthkr11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy RGGPG ayurvedic college and hospital Paprola Distt. Kangra HP 176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 176115 |
| 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 Pooja Thakur |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
9816252086
pjthkr11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (HUMAN) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers having no comorbodities and systemic illness. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhringrajadi churna, Reference: Bhaisjyaratanawali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalaki Rasayan , Reference: Bhaisjyaratanawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of either gender aged between 50-70 years. |
|
| ExclusionCriteria |
| Details |
Individuals suffering from cardiac ailment,diabetes mellitus,CKD and other major systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Bhringrajadi churna as Rasayana.
To compare the efficacy of Bhringrajadi churna with Amalaki Rasayana. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the clinical safety of Bhringrajadi Churna as rasayana |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/06/2025 |
| 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="0"
Months="2"
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
|
I would like to publish my trial after completion of trial as soon as possible. This study is a randomised open clinical trial |