| CTRI Number |
CTRI/2020/10/028358 [Registered on: 12/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of two Ayurvedic formulations in Hypertension |
Scientific Title of Study
Modification(s)
|
COMPARATIVE EVALUATION OF THE EFFICACY OF DIVYA MUKTA VATI EXTRA POWER AND SARPAGANDHA VATI IN VYANA VAISHAMYA (ESSENTIAL HYPERTENSION) |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gracy Sokiya |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8949720684 |
| Fax |
|
| Email |
gsayurveda2017@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Abhishek Bhushan Sharma |
| Address |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
|
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gracy Sokiya |
OPD no. 12 Dept of kayachikitsa Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gracy Sokiya |
Patanjali Ayurveda Hospital |
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
Hardwar
|
08949720684
gsayurveda2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2018-19/10 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Essential (primary) hypertension |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Group 1 with intervention of Mukta vati-extra power |
2 tablets of Mukta vati-extra power with normal water will be given to the patients twice daily for 1 month |
| Comparator Agent |
Group 2 with Sarpagandha vati with anupaana of normal water will be given to patients. |
2 tablets of Sarpagandha vati with normal water will be given to the patients twice daily for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 18-50 years will be selected.
2.Patients having BP <159/95 and > 130/85 will be included.
3.Patients with symptoms of Vyana vaishamya and Essential HTN will be selected for the study.
4.Patients irrespective of sex, religion, occupation will be selected for the study.
5.Both fresh and treated cases would be taken for the study. |
|
| ExclusionCriteria |
| Details |
1.Patients between the age group of 18-50 years will be selected.
2.Patients having BP <159/95 and > 130/85 will be included.
3.Patients with symptoms of Vyana vaishamya and Essential HTN will be selected for the study.
4.Patients irrespective of sex, religion, occupation will be selected for the study.
5.Both fresh and treated cases would be taken for the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TONOPORT-Ambulatory blood pressure monitoring will be done for 24 hours and examine:
1.Systolic blood pressure
2.Diastolic blood pressure
3.Mean blood pressure |
before intervention-
and during Follow up- After 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TONOPORT-Ambulatory blood pressure monitoring will be done for 24 hours and examine:
1.Systolic blood pressure
2.Diastolic blood pressure
3.Mean blood pressure |
after 15 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/10/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
not yet |
Brief Summary
Modification(s)
|
Group-A-2 tablet BD of Divya Mukta vati-extra power will be given to patients Group-B- 2 tablet BD of Sarpagandha vati will be given to patients
Both medicines will be advised to take 1 dose in morning at 9:00 a.m. after having breakfast and 2nd dose at 9:00 p.m.
Route of Administration- Oral
Follow-Up: The follow up will be done after 7 days during the trial of 15 days to observe the effects of treatment or any adverse effects on the patient. |
