| CTRI Number |
CTRI/2025/10/096164 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of Gokshuradi Kwath on Essential Hypertension |
|
Scientific Title of Study
|
Clinical Evaluation of Gokshuradi Kwath in 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 |
Nidhi |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No 2 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9992014689 |
| Fax |
|
| Email |
nidhimudgal32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnikant Rohilla |
| Designation |
H.O.D. and Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No2 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8054114530 |
| Fax |
|
| Email |
drrajnikant83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
Opd No 2 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9992014689 |
| Fax |
|
| Email |
nidhimudgal32@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nidhi Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee (247667) Haridwar India |
|
|
Primary Sponsor
|
| Name |
Nidhi |
| Address |
Opd No 2 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nidhi |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
Opd No 2 Department of Kayachikitsa Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
9992014689
nidhimudgal32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Kwath, Reference: Bhaisajya Ratnavali Chapter No. 26,Shlok No. 71, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing for trial and who sign the consent form.
2.Patients in age group between 30-60 years.
3.Patients who are freshly diagnosed with stage-1 hypertension (i.e. Systolic Blood Pressure 140-159 mm of Hg and Diastolic Blood Pressure 90-99 mm of Hg according to JNC 8.
4.Hypertension associated with/without disturbed lipid profile. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for trial.
2.Patients less than 30 years and greater than 60 years of age.
3.Patient suffering from Stage 2 hypertension i.e. Systolic grater or equal to 160 mmHg and Diastolic grater or equal to 100 mmHg and isolated systolic Hypertension (i.e. Systolic Blood Pressure grater than 140 mmHg and Diastolic Blood Pressure less than 90 mmHg).
4.Patients suffering from secondary hypertension.
5.Patients taking any other Anti Hypertensive Drug.
6.Patient suffering from any other concommitent disease like Diabetes, Cardiovascular illness, Renal disease, Neurological illness and any other comorbidity.
7.Pregnant and lactating mothers will be excluded.
8.Patients who had participated in any clinical study/trial in past 6 months.
9.Any other condition which the principal investigator thought may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Subjective Parameters:
1.Shiroruja
2.Bhrama
3.Hridadrava
4.Swasa Kricchrita |
Assesment will be done on 0 day (before treatment), and on 15th and 30th day (after the initiation of trial). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in Objective Criteria:
1.Systolic and Diastolic Blood Pressure.
2.Pulse Pressure
3.Mean Arterial Pressure
4.Pulse Pressure |
Assessment will be done on 0 day (before treatment) and on 15th and 30th day (after the initiation of 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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="1"
Months="6"
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
|
This is an single arm open labelled clinical study to evaluate the effect of Gokshuradi Kwath in Essential Hypertension for the age group between 30 years to 60 years for duration of 30 days. It will be a clinical study of 30 patients freshly diagnosed with grade 1 Essential Hypertension as per JNC 8.Patient will be randomly selected irrespective of their gender, race, religion, occupation from the OPD/IPD of Quadra Institute of Ayurveda Roorkee Uttarakhand. The assessment of the trial will be done on the basis of Subjective and Objective parameters. Data depending upon above Subjective and Objective criteria and other variables will be collected and analysed statistically. |