| CTRI Number |
CTRI/2022/03/040868 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the Efficacy of Punica Granatum in Promotion of Cardiovascular Health |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Punica Granatum in Promotion of Cardiovascular Health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
M.D. (Ay) Ph.D., Principal cum Dean |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Administrative block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Chaudhary |
| Designation |
M.D. (Ay) Ph.D., Principal cum Dean |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Chaudhary |
| Designation |
M.D. (Ay) Ph.D., Principal cum Dean |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR-IHBT, Palampur, Kangra,H.P. |
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
CSIR-New Delhi Project no. HCP 0035 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Principal |
RGGPG Ayurvedic college and Hospital, Paprola, Kangra, H.P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Vijay Chaudhary |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
IPD and OPD Department of Kayachikitsa
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I998||Other disorder of circulatory system. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo Starch , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadima, Reference: Charaka Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to undergo for the treatment.
Age between 20 -70 years.
Pre-hypertensive patients (as per JNC VII Criteria) and impaired lipid profile.
|
|
| ExclusionCriteria |
| Details |
Hypertensive patients (SBP≥140mm of Hg and/or DBP≥90mm of Hg).
Patients with FBS>150mg/dl; PPBS > 200mg/dl; RBS > 250mg/dl.
Subjects with established diagnosis of CAD requiring any procedure in next 6 months – angioplasty or bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease.
Subjects with Haemoglobin percentage < 9 gm% for males and <8gm% for females.
Patients suffering from major systemic illness necessitating long term treatment (R.A., PTB, malignancy etc.).
Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit)
Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
Any other condition which the Investigator thinks may compromise the safety of the subject.
Pregnant/ lactating women.
Patients who have participated in any clinical trial during past 6 months.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Hs-CRP from 1st day i.e. baseline to 12th week.
Change in functional capacity from 1st day i.e. baseline to 12th week.
Change in S. Lipid profile from 1st day i.e. baseline to 12th week.
Change in blood Pressure from 1st day i.e. baseline to 12th week. |
84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in FBS and HbA1c from 1st day i.e. baseline to 12th week.
Change in Heart Rate from 1st day i.e. baseline to 12th week.
Change in weight and BMI from 1st day i.e. baseline to 12th week.
Change in SF-36 health survey score from 1st day i.e. baseline to 12th week. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/03/2022 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I would like to publish my research trial after its completion as soon as possible. Patients will be studied in two groups i.e. trial group and control group. The outcome will be analyzed based on subjective and objective parameters with appropriate statistical tools. |