| CTRI Number |
CTRI/2019/11/022040 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Blood Pressure by Trivrit and Aragvadha Churna as daily mild laxative |
|
Scientific Title of Study
|
"Study the effect of Nitya Virechana with Trivrit and Aragvadha Churna in the management of Stage 1 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 |
Dr Manju Mohan |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Department of Panchakarma
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
831994245 |
| Fax |
|
| Email |
manjumohan13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Department of Panchakarma
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Department of Panchakarma
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma,
Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod(H), Wardha |
|
|
Primary Sponsor
|
| Name |
Dr Manju Mohan |
| Address |
Department of Panchakarma,
Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Wardha |
| 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 Manju Mohan |
Mahatma Gandhi Ayurved College Hospital and Research Center Salod (H) Wardha |
Department of Panchakarama OPD no. 40 Wardha
Wardha
MAHARASHTRA |
831994245
manjumohan13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
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 |
| Comparator Agent |
Group-A Trivrit Churna (Operculina terpethum Linn.) |
Group-A Trivrit Churna Nitya Virechana
Route - Oral Route
Study Duration - 30 days
Frequency -10 gms of Trivrit Churna daily for 15 days at bedtime with lukewarm water |
| Intervention |
Group-B Aragvadha Churna (Cassia fistula Linn.) |
Group-B Aragvadha Churna Nitya Virechana
Route - Oral Route
Study Duration - 30 days
Frequency -10 gms of Aragvadha Phalamajja Churna daily for 15 days at bedtime with lukewarm water |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between the age group of 30-60 yrs will be selected.
2. Newly detected cases of Stage 1 Essential Hypertension will be selected.
3. Hypertension stage 1-SBP (130-139) or DBP (80-89) will be included for the study.
|
|
| ExclusionCriteria |
| Details |
1. Hypertension associated with:
a. Cardio-vascular diseases
b. Cerebro-vascular diseases
c. Hypothyroidism
d. Diabetes Mellitus (Type 1/ Type 2/ GDM)
e. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in the symptoms and range of Blood pressure |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of Nitya Virechana with Trivrit Churna on Systolic and Diastolic blood pressure.
2. To study the effect of Nitya Virechana with Aragvadha Churna on Systolic and Diastolic blood pressure.
3. To compare the effect of Nitya Virechana with Trivrit and Aragvadha Churna on Systolic and Diastolic blood pressure.
|
Six months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
21/11/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be recruited from inclusion criteria and study the effect of Trivrit and Aragvadha Churna Nitya virechana in Stage 1 Essential Hypertension To study the effect of Nitya virechana with Trivrit Churna on systolic and diastolic blood pressure. To study the effect of Nitya virechana with Aragvadha Churna on systolic and diastolic blood pressure To compare the effect of Nitya virechana with Trivrit and Aragvadha churna on systolic and diastolic blood pressure.
|