| CTRI Number |
CTRI/2026/03/105642 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Sirodhara with Jatamansi phanta and Anulomana with Haritaki churna in the management of Raktagata vata w.s.r to Essential Hypertension. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF SIRODHARA WITH JATAMANSI PHANTA AND ANULOMANA WITH HARITAKI CHURNA IN THE MANAGEMENT OF RAKTAGATA VATA 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 Minakhee Kumari Satapathy |
| Designation |
MD (Ay.) Scholar (Dept of Panchkarma) |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
7978985020 |
| Fax |
|
| Email |
minakheesatapathy1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
H.O.D , Department of Panchkarma |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
Satyendratiwari.25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Satyendra Kumar Tiwari |
| Designation |
H.O.D , Department of Panchkarma |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
9024064735 |
| Fax |
|
| Email |
Satyendratiwari.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna,Bihar,800003 |
|
|
Primary Sponsor
|
| Name |
Dr. Minakhee Kumari Satapathy |
| Address |
Department of Panchkarma
Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna,Bihar-800003 |
| 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 Minakhee Kumari Satapathy |
Government Ayurvedic College and Hospital,patna |
OPD No-11,Panchkarma department, near Buddhamurti, Kadamkuan, Patna, Bihar
Patna
BIHAR |
7978985020
minakheesatapathy1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) |
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 | Comparator Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: Charaka Samhita , Procedure details: Sirodhara with luke warm Jatamansi phanta will be given at morning time for 21 days ( for 3 weeks with 3 days gap after each week ))
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki churna , Reference: Sharangdhar Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: guda (jaggery)), Additional Information: drug will be given at bedtime |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1st stage of essential hypertension
Range of BP 140/90 mmHg to less than 160/100 mmHg
|
|
| ExclusionCriteria |
| Details |
2nd and 3rd stage of essential hypertension
Secondary hypertension
Unstable angina, Coronary artery disease, diabetes mellitus, heart and renal failure
Patients receiving major antipsychotic drugs, NSAID or any agent that can lower BP
Patients unwilling or not able to discontinue safely the use of current Anti HTN drug during the trial period
Pregnancy induced hypertension
Patients associated with serious illness such as malignancy, HIV, TB |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in objective parameters -systolic and diastolic blood pressure |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in cardinal symptoms of the disease i.e
1.shirahshoola
2. Nidra
3. Bhrama
4. Tama
5. Arati
6. Akshirag
7. Krodha- prachurata
8. Sharira Gaurava
9. Shrama
10. Shwasakastata
11. Sattva bala
12. Urahshoola
13. Shirograha
14. Aalasya
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/03/2026 |
| 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="0"
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 study is a randomized, open, parallel group, interventional prospective trial comparing the efficacy of Sirodhara with Jatamansi phanta and Anulomana with Haritaki churna in the management of Raktagata vata w.s.r to Essential Hypertension, that will be conducted in Government Ayurvedic College and Hospital at Patna, Bihar in the Department of Panchkarma.In one group of 20 patients sirodhara with Jatamansi phanta will be done at morning time for 21 days ( for 3 weeks with 3 days gap after each week) and in another group of 20 patients Haritaki churna will be given 6 gm/ day at bedtime orally with guda( jaggery) as anupana for 30 days. The assessment will be done considering the subjective and objective parameters at pre- test i.e 0th day, 2 mid- test assessment on 7th day and 15th day respectively and post- test assessment on 30th day. |