| CTRI Number |
CTRI/2025/03/081817 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Hypertension through Ayurveda |
|
Scientific Title of Study
|
RANDOMIZED COMPARATIVE CLINICAL
STUDY TO EVALUATE THE EFFICACY OF GOKSHURADI KWATH AND KAKUBHADI CHURNA IN THE
MANAGEMENT OF AAVRIT VYAAN W.S.R. TO 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 |
Dr Aman Raj |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
7033333141 |
| Fax |
|
| Email |
amanraj.dss77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Departmen |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of
Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Departmen |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of
Kayachikitsa, Karol Bagh, New Delhi
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
| 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 Sujata Yadav |
Ayurvedic and Unani Tibbia College and Hospital |
Seminar Room,PG
Department of
Kayachikitsa
Central
DELHI |
9810571653
sujatakcdelhi@gmail.co m |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia college and Hospital |
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, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kakubhadi churna, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate and able to provide written informed consent.
Patient diagnosed as Stage- 1 Essential hypertension would be selected for study on the
basis of 8th JNC & WHO criteria. |
|
| ExclusionCriteria |
| Details |
Patient diagnosed as secondary hypertension or pre-hypertension or taking any Antihypertensive drug.
Subjects with any previous Cardiovascular disease or known cases of MI,unstable angina or CHF.
Subject suffering from any hepatic disorder
(SGPT and SGOT more than two times the upper limit of normal) or Renal dysfunction, uncontrolled Pulmonary dysfunction (asthmatic and COPD subjects).Subjects with current or past diagnosis of malignancy (any malignancy diagnosis
in last five years).Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.Subjects suffering from major systemic illness necessitating long term drug
treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).Pregnant / Lactating women.Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.Subjects who have completed participation in any other clinical trial during the past six (06) months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in Systolic & Diastolic Blood pressure. |
Baseline & Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in assessed symptoms of Essential hypertension. |
Day 1,91 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
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
|
•Hypertension
- or elevated blood pressure - is a serious medical condition that
significantly increases the risk of heart attack, stroke, kidney failure and
blindness. It is also called silent or hidden killer because most of the
sufferers (85%) are asymptomatic and as per available survey reports, in more than 95% cases of
hypertension underlying cause is not known.
•Prevalence
of hypertension is increasing in many countries as well as in India, Incidence
of Hypertension has gone up from 5% in the 1960s to nearly 12% in 1990s, and
more than 30% in 2008.
•It is
one of the leading causes of premature death worldwide killing nearly 9.4
million people every year globally.
•There
is no direct reference of Hypertension in Ayurvedic
classics by
nomenclature. So on the basis of Sign & Symptoms it can be corelated to Aavaran of Vyaan
Vaat.
|