| CTRI Number |
CTRI/2025/05/087233 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Compare the effect of Arjuna and Ashwagandha in Hypertension |
|
Scientific Title of Study
|
A Comparative clinical studty to evaluate the efficacy of Arjuna and Ashwagandha in the management of 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 Suman Prasad Sahu |
| Designation |
MD(Ay.) Scholar(Kayachikitsa) |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna, Bihar, India. |
| Address |
Department of Kayachikitsa, Government Ayurvedic College Kadamkuan Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
8825321766 |
| Fax |
|
| Email |
sahusuman133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor and Head of Department, Department of Kayachikitsa |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna, Bihar, India. |
| Address |
Department of Kayachikitsa, Government Ayurvedic College Kadamkuan Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor and Head of Department, Department of Kayachikitsa |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna, Bihar, India. |
| Address |
Department of Kayachikitsa, Government Ayurvedic College Kadamkuan Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, kadamkuan,Patna-800003 |
|
|
Primary Sponsor
|
| Name |
Dr Suman Prasad Sahu |
| Address |
Department of Kayachikitsa,Government Ayurvedic College and Hospital,kadamkuan,Patna-800003 |
| 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 Suman Prasad Sahu |
Government Ayurvedic College and Hospital, Kadamkuan, Patna-800003 |
OPD no-9,Department of Kayachikitsa,Kadamkuan,Patna-800003
Patna
BIHAR |
8825321766
sahusuman133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurvedic College, Kadamkuan, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Bhavprakash 3/189, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha +Arjuna, Reference: Bhavprakash 3/189, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Patient willing for trial.
2.The sign and symptoms based on both Ayurvedic as well as Modern view.
3.The age group of patients will be between 31-60 years.
Stage 1 of Primary Hypertension. |
|
| ExclusionCriteria |
| Details |
1.Hypertension with associated complications. 2.Pregnant women.
3.Patient having Diabetes, CKD.
4.Patient having secondary hypertension.
5.Patients suffering from chronic disease like AIDS, Cancer, T.B, Cardiac Complication. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The improvement in the patients will be assessed mainly on the basis of changes in qualitative and quantitative parameters before and after the treatment. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Repeated measurement of systolic and diastolic pressure will be done and the analysis will be done According to 8th JNC criteria for the diagnosis of hypertension. |
60 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 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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="0"
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
|
This study is randomised, parallel group, multiple arm prospective trail to study the effect of Arjuna and Ashwagandha in the management of Hypertension in a group of 60 patients. This study will be conducted in Government Ayurvedic College and Hospital,patna,Bihar in the department of Kayachikitsa. Follow up will be done every 15 days for total duration of study i.e of 60 days. |