| CTRI Number |
CTRI/2024/11/076722 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of Vacha churna and Sarpagandha churna in management of hypertension |
|
Scientific Title of Study
|
Effect of Vacha churna as compared to Sarpagandha churna in the management of stage-1 essential Hypertension:A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Rekha Gajanan Mehenge |
| Designation |
Pg Scholar |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8669442319 |
| Fax |
|
| Email |
rekhagm96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Mrityunjay Sharma |
| Designation |
Associate professor |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9373103182 |
| Fax |
|
| Email |
mrityunjaysharma22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mrityunjay Sharma |
| Designation |
Associate professor |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9373103182 |
| Fax |
|
| Email |
mrityunjaysharma22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya hanuman nagar nagpur Maharashtra India 440024 |
|
|
Primary Sponsor
|
| Name |
Vd Rekha Gajanan Mehenge |
| Address |
Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya hanuman nagar nagpur |
| 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 |
| Vd Rekha Gajanan Mehenge |
Shri ayurved pakwasa samanvaya rugnalaya Hanuman Nagar Nagpur - 440024 |
Kayachikista department OPD 1 and 2 shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya Hanuman Nagar Nagpur,440024
Nagpur
MAHARASHTRA |
8669442319
rekhagm96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Shri ayurved mahavidyalaya nagpur |
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 | Classical | | (1) Medicine Name: Vacha, Reference: Bhavprakash nighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha , Reference: Priynighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of stage -1 essential hypertension.
|
|
| ExclusionCriteria |
| Details |
Secondary hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vacha churna is more effective than Sarpagandha churna in the management of stage-1 essential hypertension |
at the end of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sarpagandha churna is more effective than Vacha churna in the management of stage-1 essential hypertension |
At the end of 30 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 3 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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
|
In the present study total 60 participants will be taken for trial dividing them in equal groups.Group A will receive the trial drug "Vacha churna" & Group B will receive the control drug "Sarpagandha churna" twice a day for internally for 30 days.Follow up will be taken every 8 days.result will be concluded based on assessment criteria. |