| CTRI Number |
CTRI/2022/08/045025 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2022 |
| 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
|
Clinical Evaluation of Tagara churna with Gokshuradi kwatha in Vyana bala vaishamya (Essential Hypertension Stage -1) |
|
Scientific Title of Study
|
Clinical Evaluation of Tagara churna along with Gokshuradi kwatha in Vyana bala vaishamya (Essential Hypertension Stage -1) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Jaya saklani kala |
| Designation |
Phd scholar |
| Affiliation |
Uttarakhand Ayurved University |
| Address |
Department of Kayachikitsa
Rishikul campus
Uttarakhand Ayurved University
Harrawala Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248160
India |
| Phone |
9927249201 |
| Fax |
|
| Email |
jk1ayush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr OP Singh |
| Designation |
Professor & HOD |
| Affiliation |
Uttarakhand Ayurved University |
| Address |
Department of Kayachikitsa
Rishikul Campus
Uttarakhand Aurved University
Harrawala Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248160
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Saklani kala |
| Designation |
Phd scholar |
| Affiliation |
Uttarakhand Ayurved University |
| Address |
Department of Kayachikitsa
Rishikul Campus
Uttarakhand Ayurved University
Harrawala Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248160
India |
| Phone |
9927249201 |
| Fax |
|
| Email |
jk1ayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Ayurveda Hospital Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurveda University |
| Address |
Harrawala Dehradun Uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jaya Saklani Kala |
Faculty of Ayurveda Hospital |
Uttarakhand Ayurved University Harrawala Dehradun
Dehradun
UTTARANCHAL |
9927249201
jk1ayush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Uttarakhand Ayurveda University Rishikul Campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: gokshuradi kashaya, Reference: bhaishajya ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: none(2) Medicine Name: tagar churna, Reference: dravyaguna vigyana p v sharma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: jala-), Additional Information: none | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Telmisartan 20mg | Angiotensin II receptor Antagonist
Antihypertensive
Dose 20mg once a day (OD) |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed patients of essential hypertension stage 1 without any complication.
1. Old cases of essential hypertension stage 1 without complications who have discontinued the antihypertensive medicine for at least 30 days
3. Age between 25 to 65 years.
4. Blood pressure measurement in the OPD (7 consecutive days)
Systolic blood pressure- 140-159 mmHg
Diastolic blood pressure- 90-99 mmHg
|
|
| ExclusionCriteria |
| Details |
1. Secondary hypertension
2. Blood pressure measurement in the OPD
Systolic blood pressure- >159 mmHg
Diastolic blood pressure- >99 mmHg
3. Any other coexisting serious medical & surgical illness.
4. Patients with complication of Hypertension.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Shiroruja
2. Hriddrava
3. Klama
4. Bhrama
5. Akshiraga
6. Krodhaprachurya
7. Alpanidra |
Assessment will be done at an interval of 15 days starting from the registration i.e.
1st Assessment at Day 15
2nd Assessment at Day 30
3rd Assessment at Day 45
4th Assessment at Day 60
5th Assessment at Day 75
6th Assessment at Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Systolic BP
2. Diastolic BP |
Assessment will be done at an interval of 15 days starting from the registration i.e.
1st Assessment at Day 15
2nd Assessment at Day 30
3rd Assessment at Day 45
4th Assessment at Day 60
5th Assessment at Day 75
6th Assessment at Day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jk1ayush@gmail.com].
- For how long will this data be available start date provided 05-08-2025 and end date provided 05-08-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The trial will be conducted as a part of Phd thesis. A regime of Tagar churna 500mg bd and Gokshuradi kwatha 40ml bd will be given to one group while the other group will be prescribed Telmisartan 40mg od Duration of the drug trial will be 90 days Each group will have 50 patients who will be selected randomly The trial with the above said sample size will be completed within 2 years (24months)
|