| CTRI Number |
CTRI/2025/07/091352 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Benefits of Herbal Water Therapy and Plain Water Therapy in People with Early- Stage High Blood Pressure |
|
Scientific Title of Study
|
A Comparative Study on Efficacy of Kashayadhara and Jaladhara in Pre-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 Reshmi Babu |
| Designation |
Phd Scholar |
| Affiliation |
Faculty of Indian Medical System, SGT University |
| Address |
Department of Panchakarma
Faculty of Indian Medical System
SGT University
Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9620704180 |
| Fax |
|
| Email |
drreshmibabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Phull |
| Designation |
HOD and Professor Kayachikitsa |
| Affiliation |
Faculty of Indian Medical System, SGT University |
| Address |
Department of Kayachikitsa
Faculty of Indian Medical System
SGT University
Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9555953332 |
| Fax |
|
| Email |
rekha.ayurveda@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshmi Babu |
| Designation |
Phd Scholar |
| Affiliation |
Faculty of Indian Medical System, SGT University |
| Address |
Department of Panchakarma
Faculty of Indian Medical System
SGT University
Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9620704180 |
| Fax |
|
| Email |
drreshmibabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil,its a Phd study in private college |
|
|
Primary Sponsor
|
| Name |
Dr Reshmi Babu |
| Address |
Department of Panchakarma
Faculty of Indian Medical System
SGT University |
| Type of Sponsor |
Private 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 Reshmi Babu |
G S Ayurveda Medical College and Hospital |
G S Ayurveda Medical College and Hospital,Department of Panchakarma,
Panchakarma hospital wing,first Floor,Shirodhara Kaksha,Pilakhuwa,Hapur
Ghaziabad
UTTAR PRADESH |
9620704180
drreshmibabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of G S Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R030||Elevated blood-pressure reading, without diagnosis of hypertension. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | shirodhara | (Procedure Reference: Shirodhara – Sahasrayoga Taila Yoga Prakarana & standard Panchakarma protocols, Procedure details: Shirodhara with Jatamayadi Kashaya, 52 minutes daily for 7 days)
(1) Medicine Name: Jatamayadi Kasmaya, Reference: Sahasrayoga, Taila Yoga Prakarana, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | shirodhar | (Procedure Reference: As per the Classical text and Shirodhara Protocol, Procedure details: Shirodhara with Jala (Plain Water), 52 minutes daily for 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Pre hypertension without taking any anti hypertensive drug.
Either sex, irrespective of religion and caste.
Prehypertension (SBP 120 to 139 mm Hg and DBP 80 to 89 mm Hg).
|
|
| ExclusionCriteria |
| Details |
Patients below 20 yr and above 50 yr.
Patients with Stage 1 HTN and Stage 2 HTN.
Patients receiving antihypertensive drug.
Patients having any other systemic disease or complications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Jatamayadi Kashayadhara in Pre-Hypertension when measured in Sphygnomanometer, WHO’s QOL Scale and on the basis of signs and symptoms of Pre-Hypertension.
To evaluate the efficacy of Jaladhara in Pre-Hypertension when measured in WHO’s QOL Scale and on the basis of signs and symptoms of Pre-Hypertension.
To compare the efficacy of Jatamayadi Kashayadhara and Jaladhara in Pre-Hypertension
|
Total duration of study is 14 days
with observation
Initially on the first day before treatment.
On the 7th day after treatment.
On the 14th day for late assessment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective symptoms of Pre-Hypertension (e.g., headache, dizziness, irritability, fatigue, insomnia, belching, burning sensation)
Improvement in WHO Quality of Life (QOL) score |
Day 1 (before treatment), Day 7 (after intervention), and Day 14 (follow-up) |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
10/08/2025 |
| 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="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included drreshmibabu@gmail.com).
- For how long will this data be available start date provided 10-08-2025 and end date provided 08-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is a randomized, parallel-group, active-controlled, interventional clinical trial designed to compare the efficacy of Kashayadhara (using Jatamayadi Kashaya) and Jaladhara (using plain water) in patients with pre-hypertension. A total of 140 participants diagnosed with pre-hypertension will be randomly allocated into two groups: • Group A: Kashayadhara • Group B: Jaladhara
Each intervention will be administered as Shirodhara for 52 minutes daily over 7 days, followed by a late assessment on Day 14. The primary outcome is the change in blood pressure measured by sphygmomanometer. Secondary outcomes include improvements in subjective symptoms and WHO Quality of Life Scale (QOL). The study will be conducted at the Department of Panchakarma, G S Ayurveda Medical college and Hospital, Pilakhuwa, Hapur Dist This trial aims to explore and validate the efficacy of Ayurvedic Panchakarma therapies in managing early-stage high blood pressure. |