| CTRI Number |
CTRI/2020/07/026483 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Experimental and clinical trial to study the effect of Triphala Rasayana |
|
Scientific Title of Study
|
A Pre-clinical and clinical study to evaluate the efficacy of Triphala as Rasayana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjana Mishra |
| Designation |
Associate Professor |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, VPO Paprola, Tehsil Baijnath
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjana Mishra |
| Designation |
Associate Professor |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, VPO Paprola, Tehsil Baijnath
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Thakur |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, VPO Paprola, Tehsil Baijnath
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8894894331 |
| Fax |
|
| Email |
pooji.thakur009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Institute in I.S.M Jogindernagar Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital VPO Paprola, distt Kangra (h.P) |
| 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 Anjana Mishra |
Rajiv Gandhi Ayurvedic College and Hospital |
Room No. 315, Department of Kayachikitsa, Paprola Division
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age 30 to 60 Years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triphala Churan |
5 gram twice a day with anupana Madhu Ghrita orally for 8 weeks duration
Reference- Sharangdhar Ch.6 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy individuals willing to undergo trial.
2) Individuals ready to give written consent.
3) Healthy volunteers of either sex aged between 30 to 60 years.
4) Individuals willing to participate for 8 weeks duration
|
|
| ExclusionCriteria |
| Details |
1) Individuals not willing to undergo the clinical trial.
2) Individuals below 30 and above 60 years of age.
3) History of hypersensitivity to the drug or its ingredients.
4) Who have participated in any other trial during past 6 months.
5) Any other condition which is considered unfit for inclusion in trial. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
I would like to publish my Research trial after completion of the trial as soon as possible. Healthy volunteers will be selected from campus/ Faculty/OPD of RGGPG Ayurvedic College and Hospital Paprola. 30 individuals will be registered and assessed on the basis of general physical fitness to know the effect of Triphala Rasayana.
|