| CTRI Number |
CTRI/2026/01/100964 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Effectiveness of Sarpagandha Extract Mansyadi Kwatha and Jaladhara Therapy in the Treatment of Essential Hypertension |
|
Scientific Title of Study
|
An Open-Label Randomised Controlled Clinical Study to Evaluate the Efficacy of Sarpagandha Extract Mansyadi Kwatha and Jaladhara in the Management of Essential Hypertension |
| 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 DR VIJAY CHAUDHARY |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Hospital building Room Number 317 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Panchrukhi Road VPO Paprola Teh Baijnath District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANIK SONI |
| Designation |
Senior Lecturer |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Hospital building Room Number 317 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Panchrukhi Road VPO Paprola Teh Baijnath District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219121014 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIPUN GUPTA |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Hospital building Room Number 317 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Panchrukhi Road VPO Paprola Teh Baijnath District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8360468034 |
| Fax |
|
| Email |
guptanipun07121996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Government Ayurvedic College and Hospital Paprola Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh |
| 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 |
| NIPUN GUPTA |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh |
Opd and ipd of Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Panchrukhi Road VPO Paprola Teh Baijnath District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
8360468034
guptanipun07121996@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 |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: SIRAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha extract , Reference: Dravyaguna Vijnana by Prof PV Sharma reprint year 2001, Route: Oral, Dosage Form: Sattva, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -mansyadi kwatha ), Additional Information: -500 mg capsule would be made for the easy of palatability which would further consist of 100 mg Sarpagandha extract and 400 mg starch
The dose of Mansyadi Kwatha would be 40 ml twice daily for 45 days and the kwatha dravya will be taken as 13 gm in two equal divided doses each day
The procedure named Jaladhara will be performed once daily for 45 days along with drugs. | | 2 | Comparator Arm (Non Ayurveda) | | - | Telmisartan | Tab telmisartan 40 mg OD for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A. Patients of either gender aged 18-70 years suffering from stage-I hypertension will be included in trial.
Stage-I of JNC 8 th report.
Systolic - 140-159mm of Hg
Diastolic - 90- 99mm of Hg
B. Patients willing and able to participate for 45 days of duration. |
|
| ExclusionCriteria |
| Details |
A. Individuals not willing to undergo the clinical trial.
B. Patients below age of 18 years and above 70 years of age.
C. Patients with Systolic B.P more than or equal to 160 mm of Hg and Diastolic B.P more than or equal to 100 mm of Hg.
D. All the patients of secondary hypertension.
E. Women who are pregnant or lactating.
F. Hypertension associated with target organ damage.
G. Having evidence of malignancy.
H. Patients suffering from depressive disorder or on anti- depressive drugs.
I. Who have completed participation in any other clinical trial during the past six months.
J. History of hypersensitivity to any of the trial drug or other ingredients.
K. Any other condition which the principal investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Sarpagandha extract, Mansyadi Kwatha and Jaladhara in the Management of Essential Hypertension. |
After every fifteen days till the end of the trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the clinical safety and untoward effect of Sarpagandha Extract, Mansyadi Kwatha and Jaladhara in the patients of Essential Hypertension.
• To compare the efficacy of Sarpagandha Extract, Mansyadi Kwatha and Jaladhara with Telmisartan in the Management of Essential Hypertension. |
After every fifteen days till the end of the trial |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2027 |
| 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="1"
Days="15" |
|
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
|
The trial on essential hypertension consists of two groups. One interventional arm consist of administration of Sarpagandha extract capsules, Mansyadi Kwatha and Jaladhara. This will be compared with comparer arm administered with tab telmisartan. The trial would be carried out for 45 days and 30 patients would be registered for the trial. The purpose of the trial is to determine the efficacy of Sarpagandha extract Mansyadi Kwatha and Jaladhara in the Management of essential hypertension. Also to assess the clinical safety and untoward effect of these interventions. Further this trial will also compare the efficacy of Sarpagandha extract Mansyadi Kwatha and Jaladhara with Telmisartan in the Management of essential hypertension. |