| CTRI Number |
CTRI/2025/07/090559 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of musta amalaki takradhara in the management of Hypertension |
|
Scientific Title of Study
|
An open randomized control clinical trial of musta amalaki takradhara in uccha rakta chapa with special reference 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 Shivani Sunil Nirmal |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
OPD No 09 Panchakarma OPD ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9623364323 |
| Fax |
|
| Email |
shivaninirmal051@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alaknanda Kulkarni |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860359489 |
| Fax |
|
| Email |
Vdalaknandakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alaknanda Kulkarni |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860359489 |
| Fax |
|
| Email |
Vdalaknandakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta, Maharashtra. India 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Sunil Nirmal |
| Address |
OPD NO 09 Panchakarma OPD ground floor Dhanvantari Ayurved Hospital Ashta, Maharashtra,India 416301 |
| 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 Shivani Sunil Nirmal |
Hon Shri Annasaheb Dange Ayueved Medical College Post Graduate and Research Center Ashta |
OPD NO 09 Panchakarma OPD ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9623364323
shivaninirmal051@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | takradhArA, तक्रधारा | (Procedure Reference: Dharakalp, Procedure details: 1 Purvakarma i Counselling and consent for karma ii Sambhar sangraha iii Preparation of Musta Amalaki siddha Takra iv Patient will be asked to lie down on table 2 Pradhankarma Dhara of Siddha Takra poured on the forehead for about 30 to 45 minutes 3 Paschatkarma i Rest for about 15 to 30 minutes ii Take warm water head bath )
(1) Medicine Name: Musta Amalaki siddha Takra, Reference: Dharakalp, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | SiraHsekaH, शिरःसेकः | (Procedure Reference: Ashtang Hridaya, Procedure details: 1 Purvakarma i Counselling and consent for karma ii Sambhar sangraha iii Preparation of Manasyadi kwath iv Patient will be asked to lie down on table 2 Pradhankarma Dhara of Manasyadi kwath poured on the forehead for about 30 to 45 minutes 3 Paschatkarma i Rest for about 15 to 30 minutes ii Take warm water head bath )
(1) Medicine Name: Manasyadi kwath, Reference: Siddhayog Sangraha, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Essential Hypertension Systolic blood pressure is 140 to 159 mm of Hg and diastolic blood pressure is 90 to 99 mm of Hg with or without allopathic medicine
Chronicity less than 2 years |
|
| ExclusionCriteria |
| Details |
Secondary Hypertension
Pregnancy induced hypertension
Gestational hypertension
Patients having history of acute coronary syndrome cardiomyopathies MI Stroke
Pregnant and lactating womens
Alcohol and drug abusers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of musta amalaki takradhara in Uccha Rakta Chapa |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review Uccha Rakta Chapa in detail
2 To review Essential Hypertension in detail
3 To review Takradhara procedure for Hypertension
4 To review Manasyadi Kwath Shirodhara procedure for Hypertension
5 To find out adverse drug reaction of either drug or procedure |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
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="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
|
Hypertension is one of the most common lifestyle diseases in present era. It is a major global public health problem due to its high prevalence. Uccha Rakta Chapa is a chronic medical condition caused by persistently elevated blood pressure in the arteries. When the Systolic blood pressure remains elevated above 140mmHg and Diastolic blood pressure remains elevated above 90mmHg. It is considered as Hypertension. It is classified into Primary (Essential) Hypertension and Secondary Hypertension. Essential Hypertension is one of life-threatening disorder of today’s life which has psychosomatic and hereditary background results from variety of reasons like stressful psychological conditions, faulty life style, obesity, over use of salts etc. It is called a silent killer because it rarely exhibits symptoms before it damages the heart, brain, or kidney. According to Acharya Charaka’s concepts it is a manifestation of Dushta Rakta and can be treated with therapeutics of Shita, Ushna, Snigdha kriya. In present research I have selected same concept by adoption of Shirodhara; one of the type of Murdha Taila, which pacifies Sharira and Manasa Dosha to overcome Essential Hypertension. |