| CTRI Number |
CTRI/2026/02/104725 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Therapies in the management of Primary Hypertension |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the efficacy of virechana karma and ksheeradhara in raktagatavata w.s.r hypertension with sarpagandha churna as shamana aushadhi. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayantan Bera |
| Designation |
Reader, Department Of Panchakarma |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Panchakarma, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9477150388 |
| Fax |
|
| Email |
dr.sayantanbera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallabi Mukherjee |
| Designation |
Associate Professor and HOD, Department of Kayachikitsa and Panchakarma |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Panchakarma, Room No 2 and 4
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9836362763 |
| Fax |
|
| Email |
dr.tapasbhaduri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahil Sk |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Panchakarma, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
8250462851 |
| Fax |
|
| Email |
sahil0205sk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Health and family welfare
Swasthyabhawan
sectar V
GN 29
Saltlake City
Kolkata 700091 |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
294/3/1 APC Road, Kolkata 700009 |
| 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 Sahil Sk |
Institute of post graduate ayurvedic education and research at SVSP Hospital |
Dept. of Panchakarma, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata, West Bengal-700009
Kolkata
WEST BENGAL |
08250462851
sahil0205sk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Agnivesha,Caraka samhita ,Vidyotini Hindi commentry by Pgt.kashi natha sastri , Chaukhambha sanskrit sansthan,Varanasi Reprint,2012,Vol-II, Cikitshasthana,CH-28,707P, Procedure details: Virechana karma with Trivit Lehyam.
Purva Karma-▪ Deepana -Pachana of the patients will be done by –Panchakola churna – Dose3g.
Time of intake- Thrice daily before food.
Anupana- Luke warm water.
Route of administration- Oral.
Duration- According to kostha and agni of patients upto 7-10 days.
▪ Snehapana of patients will be done Sunthi Ghrita / Tila taila.
Dose- According to kostha and agni of patients till Samyak Sneha lakshana appears.
(max. 7 days).
Anupana- Luke warm water.
Route of administration- Orally.
Time of administrationPradhana Karma- After proper snehana and swedana, Virechana Yoga will be
Administered.
Trivrit lehyam – Dose- According to patient`s Kostha.
Time of intake- Within 9 a.m.
-Anupana- Luke warm water.
-Route of administration- Oral.
Paschyat Karma- Samsarjana Krama will be planned according to the type of shuddhi of the
Patient.
Follow up-45 days)
(1) Medicine Name: Sarpagandha Churna, Reference: Sastry J.L.N. Illustrated Dravyaguna Vijnana (Study of the Essential medicinal Plants in Ayurveda). Vol II, Reprint Ed. Varanasi: Chaukhambha Orientalia; 2011, 334P, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Procedure | - | SirobastiH, शिरोबस्तिः | (Procedure Reference: Deveaj T.L,The Panchakarma treatment of Ayurveda With Kerala Specialities, Chaukhambha Publisher,Varanasi ,First edition, Revised and Enlarged Delhi2006,106P, Procedure details: Purvakarma: tSelected Patient is adviced to lie down on a Droni ,Proper abyanga done on
scalp , forehead,cheek,neck,etc by vatari oil .A cotton thread tied around the head over the
eyebrow,eye pad and cotton pad should be placed properly .
Pradhana Karma: ksheera (2-3) 4 litre is mildly heated and keep on Dhara patra then it
should be pour on the forehead in a specific rhythm along with dhara from one side to
another side ,mild massage should be done on the scalp during the process along with dhara.
Paschat karma:After completion of ksheeradhara for Stimulated perood cotton pad and
cotton thread should be removed and clean the head and adjacent area with a towel soaked in
luke warm water.)
(1) Medicine Name: Sarpagandha Churna, Reference: Sastry J.L.N. Illustrated Dravyaguna Vijnana (Study of the Essential medicinal Plants in Ayurveda). Vol II, Reprint Ed. Varanasi: Chaukhambha Orientalia; 2011, 334P, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of sex, race and religion
Systole Blood Pressure within 140-159 mm of Hg
Diastolic Blood Pressure within 90 to 99 mm Hg
Participants are not taking any hypertensive anti lipidemic medication for 3 months prior to enrollment |
|
| ExclusionCriteria |
| Details |
Patients with cardiac failure, congenital heart diseases, renal failure
Prehypertensive with uncontrolled diabetes
Abuse of alcohol and drugs
Pregnant mother |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 to reduce Systolic blood pressure from 159 mm of hg to 140 mm of hg
to reduce diastolic blood pressure from 99 of hg to 90 mm of Hg
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to observed the symptoms of pain
any abnormal body temperature
discoloration of skin
any body weight reduction
|
45 days |
|
|
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)
|
15/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 most common lifestyle disorder, It is chronic and often
asymptomatic medical condition where BP elevated beyond normal limit.Various Ayurvedic
scholar coined different name of Hypertension,Here Raktagatavata is corelated with
Hypertension. Hypertension is directly responsible for 57% of all stroke deaths and 24% of all
coronary heart dis-ease (CHD) deaths in India. It is the most potent risk factor for diseases of
the brain, kidney, heart and peripheral arteries which may prove fatal if not man-aged
effectively. Hypertension is a silent killer be-cause most sufferers (85%) are asymptomatic. In
95% of the cases of hypertension, the exact underlying cause is still unknown but is believed
to be due to genetic and environmental factors. Hypertension can-not be considered as a Vyadhi
(Disease) as per Ayurveda, but it can be understood by assessing the in-volved Doshas,
Dooshyas (Entity which is affected by morbid Dosha), Srotas etc. Many Ayurvedic scholars
have proposed different theories about how hypertension can be understood in Ayurveda, but
there is no standardized and widely accepted view about the Ayurvedic pathogenesis of this
condition. Thus, an attempt is made to understand the Samprapti of various types of
hypertensions and to find an ideal Chikitsa Sutra ( treatment protocol)2-4 for the management
of Raktagatavata.In this Study virechana and ksheeradhara has been applied along with
Sarpagandha churna in Raktagatava. In modern medicine there are lots of Complication like,
Pedal oedema, left ventricular hypcotrophy, So in Ayurvedic Medicine and therapy there is
long lasting effect of over the disease hypertension and no side effects. This is a single centred two arm parallel group with blinded outcome,randomized
control trial .Total 60 patient with (30-65) years of age irrespectively of sex , Primary Hypertension
(Systolic 140-159 mm of Hg and Diastolic 90- 99 mm of Hg) will be divided into two groups.One
on Virechana karma by Trivit Lehyam along with powder sarpagandha, second one ksheeradhara
along with powder sarpagandha will be given to the participants.person will be selected strictly on
the basis of inclusion and exclusion criteria for this trial programme. |