| CTRI Number |
CTRI/2026/01/100056 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Rudraksha seed in management of high blood pressure |
|
Scientific Title of Study
|
Pharmacognostical and Clinical study evaluating the efficacy of Rudraksha seed (Elaeocarpus ganitrus Roxb) in the management of 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 Diksha Sharma |
| Designation |
MD Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09459806971 |
| Fax |
|
| Email |
sharmadiksha9887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof AK Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8874600002 |
| Fax |
|
| Email |
anilkumar.singh113@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof AK Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8874600002 |
| Fax |
|
| Email |
anilkumar.singh113@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India Pin code 221005 |
|
|
Primary Sponsor
|
| Name |
Department of Dravyaguna Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India |
| 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 Diksha Sharma |
Sir Sunderlal Hospital |
OPD Department of Dravyaguna Indian Medicine Wing Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH |
9459806971
sharmadiksha9887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: SIRAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rudraksha , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Sheetodaka), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Antihypertensive drug | Ramipril 5mg OD after meal |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Stage 1 Essential Hypertension as per 8th JNC criteria
Patients who are willing to participate in the study
Patients with no significant change in their therapy over last 4 weeks prior to entry into the study |
|
| ExclusionCriteria |
| Details |
Known case of secondary hypertension e.g. Thyrotoxicosis, Renal artery stenosis, Pheochromocytoma etc.
Known case of renal disease, Diabetes mellitus
Known case of ventricular hypertrophy and coarctation of aorta.
Known case of portal hypertension
Women who were pregnant or were in the postpartum period or lactating.
Any inflammatory conditions like RA, SLE, IBD, Ankylosing Spondylitis.
Chronic Alcoholic and Chronic smokers
Patients suffering from the systemic or serious illness like Leukemia, Chronic Kidney diseases, cirrhosis of liver, myocardial infarction, malignancy etc.
Patient with evidence of any target organ damage. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood Pressure |
6 follow ups at 15 days interval each
After completion of trial, 2 follow ups at 15 days interval each |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
06/03/2026 |
| 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="7"
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
|
108 participants will be selected having Stage 1 Essential hypertension. 54 participants will be given with Rudraksh seed powder 5gm OD and 54 participants will be given Ramipril 5mg OD. The difference in reduction in blood pressure will be statistically analysed. |