| CTRI Number |
CTRI/2025/12/098783 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| 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
|
RUDRAKSHA CHURNA vs
JATAMANSYADI KWATH CHURNA IN
STAGE-1 HYPERTENSION |
|
Scientific Title of Study
|
A Parallel Comparative Study To Evaluate The Efficacy Of Rudraksha Churna In Comparison To Jatamansyadi Kwath Churna In The Management of Stage-1 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 Divya |
| Designation |
Pg scholar |
| Affiliation |
Institute for Ayurved Studies and Reasearch kurukshetra |
| Address |
Room no 56 PG Department of kayachikitsa
Institute for Ayurved Studies and Reasearch kurukshetra Shri Krishna Ayush University kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8168679351 |
| Fax |
|
| Email |
divyaasiradhna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Chairperson department of kayachikitsa |
| Affiliation |
Institute for Ayurved Studies and Reasearch kurukshetra |
| Address |
Room no 56 PG Department of kayachikitsa
Institute for Ayurved Studies and Reasearch kurukshetra Shri Krishna Ayush University kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya |
| Designation |
Pg scholar |
| Affiliation |
Institute for Ayurved Studies and Reasearch kurukshetra |
| Address |
Room no 56 PG Department of kayachikitsa
Institute for Ayurved Studies and Reasearch kurukshetra Shri Krishna Ayush University kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8168679351 |
| Fax |
|
| Email |
divyaasiradhna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research
Shri Krishna Ayush University
Kurukshetra
136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and research |
| Address |
Umri road sector 8
Kurukshetra
136118 |
| 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 Divya |
Institute for Ayurved studies and research |
Room no 56 PG Department of kayachikitsa
Institute for Ayurved studies and research, Shri krishna AYUSH university
Kurukshetra
136118
Kurukshetra
HARYANA |
8168679351
divyaasiradhna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RUDRAKSHA CHURNA, Reference: PRIYAVRATA SHARMA, VOLUME 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: JATAMANSYADI KWATH CHURNA, Reference: AYURVEDIC FORMULARY OF INDIA, PART III, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing for clinical trial and ready to give written Consent.
2. Patients between the age group of 30 - 60 years of either gender.
3. Pre-diagnosed or freshly diagnosed patient of Stage-1 Hypertension.
4. SBP 140-159mmhg, DBP 90-99mmhg (HTN stage 1). |
|
| ExclusionCriteria |
| Details |
1. Patient having an Age below 30 and above 60 years.
2. SBP greater than 160 mmhg, DBP greater than 100 mmhg (HTN stage 2).
3. Cases linked renal, endocrine, cardiovascular diseases (Secondary Hypertension).
4. Other systemic diseases such as Diabetes, CKD etc.
5. Pregnancy and Lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Rudraksha Churna and Jatamansyadi
Kwath Churna in reducing systolic and diastolic blood pressure. |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in World Health Organization Quality of life (WHOQOL Bref) Scale Score,
Improvement in Hamilton Anxiety Rating Scale Score (HAM-A).
Improvement in the lipid profile. |
28 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)
|
15/05/2026 |
| 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 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
|
Raktagata vata can be understood by assessing the involved Doshas, Dooshyas, Srotases, Samuthan. Sharira doshas (Vata - Pitta - Kapha) and Mansika doshas (Raja - Tama) gets vitiated by nidana sewans which leads to Agni Mandhya, Dhatu Dushti (Rasa-Rakta) and Srotodushti (Rasavaha-Raktavaha). As a result of this Vyana Prakopa takes place and Sthanasamsraya occurs in Dhamni, Shira and Sarwang Sharira due to the Vikshepa bala of Vyana Vayu which leads to rise in the blood pressure. In Raktagata vata, Rakta dhatu gets vitiated by Vata dosha, leading and it is unable to perform its normal function and symptoms like Tivraruja, Santapa, Vaivarnya, Aruchi, Krishata Bhrama, Klama, Shirashula can be observed in the patient. According to Acharya Charaka to understand a new clinical entity, which is not described in the Samhita and physician is unable to diagnose the disease, then the treatment protocol should be designed by assessing its Prakruti, Samuthan and Adhishtana . Cardiovascular diseases (CVDs) are the leading cause of death worldwide, and many of these deaths can be prevented by treating hypertension. Blood pressure is created by the force of blood pushing against the walls of blood vessels (arteries) as it is pumped by the heart. The higher the pressure, the harder the heart must pump and the more damage this excess pressure causes to many parts of the body, especially the brain, heart and kidneys. In about 85% -95% of cases, a specific underlying cause of hypertension cannot be identified and such hypertension is termed as essential hypertension. To catalyze national action, the World Health Assembly adopted a comprehensive Global Monitoring Framework in 2013, comprised of nine voluntary global targets to be reached by 2025 which included a 25% relative reduction in the prevalence of raised blood pressure.
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