| CTRI Number |
CTRI/2019/05/019423 [Registered on: 29/05/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of ayurvedic drug formualtion Amrutadi Yog in patients with high blood presssure. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Amrutadi Yog in Essential Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VARSHA SADASHIV KHOT |
| Designation |
Assistent Professor |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Dhanvantari Hospital,Ashta.
Deapartment of Kayachikitsa,
OPD Room No 1.
MAM SSAMs Sane Guruji Arogya Kendra Hadapsar,Pune 411028
Department Of Kayachikitsa
OPD Room No 1
OPD Room No 2
Sangli
MAHARASHTRA
416301
India |
| Phone |
09423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VARSHA SADASHIV KHOT |
| Designation |
Assistent Professor |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Dhanvantari Hospital,Ashta,
Deapartment of Kayachikitsa,
OPD Room No 1.
MAM SSAMs Sane Guruji Arogya Kendra Hadapsar,Pune.411028
Department Of Kayachikitsa
OPD Room No 1
OPD Room No 2
Sangli
MAHARASHTRA
416313
India |
| Phone |
09423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VARSHA SADASHIV KHOT |
| Designation |
Assistent Professor |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Dhanvantari Hospital,Ashta.
Deapartment of Kayachikitsa,
OPD Room No 1.
MAM SSAMs Sane Guruji Arogya Kendra Hadapsar,Pune.411028
Department Of Kayachikitsa
OPD Room No 1
OPD Room No 2
Sangli
MAHARASHTRA
416313
India |
| Phone |
09423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material will purchased from Manakranika Aoushdhalaya Pune |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| private college |
SSAM College Pune
ADAMC AShta Sangli |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Varsha Khot |
Dhanvantari Hospital Ashta |
Deapartment of Kayachikitsa,
OPD Room No 1.,
Hon. Shri. Annasaheb Dange Ayurved Medical College, Dhanvantari Hospital,Ashta.
Sangli
MAHARASHTRA |
09423565886
drvarshaskhot@gmail.com |
| Varsha Khot |
MAM SSAMs Sane Guruji Arogya Kendra |
Department of Kayachikitsa, OPD Room No 1, OPD Room no 2,MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune. 411028
Pune
MAHARASHTRA |
09423565886
drvarshaskhot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAM Sumatibhai Shah Ayurved Pune College Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutadi Yog |
Amrutadi Yog
1 gram
twice in a day
after meal
Total Duration of Therapy- 8 weeks |
| Comparator Agent |
Tb Telmisartan |
Tb. Telmisartan
20 mili gram
Once in a Day
Total Duration of Therapy- 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of stage 1 essential hypertension with blood pressure systolic blood pressure is equal to and more than 140 mmHg and less than 160 mmHg and diastolic blood pressure is equal to and more than 90 mmHg and less than 100 mmHg |
|
| ExclusionCriteria |
| Details |
1.Patients receiving anti-hypertensive drug.
2.Complicated hypertensive cases.
Known case of Nephropathy, Left Ventricular Hypertrophy, heart block, Congestive Cardiac Failure, Coronary Artery Disease and retinopathy. Patients suffering from Diabetes Mellitus and severe other illness like hepatic or renal failure.
3.Secondary, Accelerated and Malignant Hypertension
4.Patients taking steroids, oral contraceptive pills, estrogen replacement therapy or NSAIDS group of drug
5.Pregnant women or planning pregnancy within six months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduction in blood pressure
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sign and symptoms of hypertension rlief |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/07/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomised controlled trial to evaluate the efficasy of ayurvedic formulation amrutadi yog which contains Amruta Tinospora cordifolia Willd. Miers.exHK.F.and Th., Gokshur Tribulus terrestris Linn, Jatamansi Nordostachys jatamansi (D.Don) DC. Parsik Yavani, Hysocymus niger Linn. Amalaki Phyllanthus emblica Linn Haritaki Terminalia chebula Retz. Trial drug dose 1 gm bid and control drug dose 20 mg once in day in the morning for 8 weeks for 110 patients in each group. study will be conducted in India. outcome of study will be asses on reduction of blood pressure and sign symptoms of hypertension. |