| CTRI Number |
CTRI/2025/09/095504 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the efficacy of Pushkarmoola Ghan Vati and Sarpagandha Ghan Vati with Lifestyle Modification in the treatment of stage 1 hypertension |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Pushkarmoola Ghan Vati versus Sarpagandha Ghan Vati along with Lifestyle Modifications in the Management of Stage-1 Hypertension - A Randomized Controlled Trial |
| 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 Pooja Umeshchand Singh |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha MAHARASHTRA 442001 India
Plot No 26 Padmavati Nagar Alodi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923210674 |
| Fax |
|
| Email |
poojausingh2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Waskar |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha MAHARASHTRA 442001 India
Plot No. 26, Padmavati Nagar, Alodi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7218182090 |
| Fax |
|
| Email |
rohit9642@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Waskar |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha MAHARASHTRA 442001 India
Plot No. 26 Padmavati Nagar, Alodi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7218182090 |
| Fax |
|
| Email |
rohit9642@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha Hirapur MAHARASHTRA India 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Umeshchand Singh |
Mahatma Gandhi Ayurved College Hospital and Research Center |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha MAHARASHTRA 442001 India
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA |
09923210674
poojausingh2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pushkarmool Ghan Vati, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha Ghan Vati, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate with written informed consent.
Age between 35-55 years of either sex
Subjects having Systolic blood pressure 130- 139 mmHg & Diastolic blood pressure between
80- 89 mmHg (Stage-1 hypertension as per ACC/AHA 2017 guidelines)
|
|
| ExclusionCriteria |
| Details |
Cases of major illness like cardiovascular disorders like cardiogenic shock, unstable angina, aortic stenosis, diabetes mellitus, and renal disorders.
Patients taking medication like glucocorticoids
Pregnant and lactating women.
Patient on antihypertensive and diuretic drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in systolic blood pressure (SBP)
Reduction in diastolic blood pressure (DBP)
Reduction in mean arterial pressure (MAP)
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="6"
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
|
Volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. Clinical research format will be prepared and validated prior the study. Approval will be taken from the IEC from MGACHRC, Salod (H ) Wardha and after selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomised Standard Control Equivalence Clinical Trial. It will include a 60-day treatment period and follow-up visits on the 10th and 20th days after treatment. |