| CTRI Number |
CTRI/2018/08/015228 [Registered on: 07/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of Homoeopathy and life style modification in stage I hypertension |
|
Scientific Title of Study
|
Effects of homoeopathic intervention in stage I essential hypertensive patients: a randomized double blind, placebo controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K Manchanda |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy 61-65 Institutional area Opp D block Janakpuri New Delhi 110058
New Delhi
DELHI
110058
India |
| Phone |
011-28521162 |
| Fax |
011-28521060 |
| Email |
rkmanchanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional area Opp D block Janakpuri New Delhi 110058
New Delhi
DELHI
110058
India |
| Phone |
011-28525523 |
| Fax |
011-28521060 |
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Scientist 2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional area Opp D block Janakpuri New Delhi 110058
New Delhi
DELHI
110058
India |
| Phone |
011-28525523 |
| Fax |
011-28521060 |
| Email |
varanasiroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy
61-65 Institutional area Opp D block Janakpuri New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional area Opp D block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Papula Prasad |
Clinical Research Unit (H) Chennai |
Clinical Research Unit (H)
No B-32 3 Cross Street A G S Colony (Sea Side) Kottivakkam
Chennai 60004
Chennai
TAMIL NADU |
09840771619
drpprasad2012@gmail.com |
| Dr G Ravi C Reddy |
Clinical Research Unit (H) Tirupathi |
Clinical Research Unit (H)Old Maternity Hospital Campus
Tirupathi 517507
Chittoor
ANDHRA PRADESH |
09441208007
dr.grcreddy@gmail.com |
| Dr D B Sarkar |
Dr. Anjali Chatterjee Regional Research Institute Kolkata |
Dr Anjali Chatterjee Regional Research Institute for Homoeopathy 50 Rajendra Chatterjee Road Kolkata 700 046
Kolkata
WEST BENGAL |
09432086690
kcdas1955@gmail.com |
| Dr Hafeezullah Baig |
Drug Standardization Extension Unit Hyderabad |
Drug Standardization Extension Unit Hyderabad
Princess Durru Shevvar
Children & General Hospital, Purani haveli
Hyderabad Andhra Pradesh 500002
Hyderabad
ANDHRA PRADESH |
9440922309
drhafeezullahbaig@gmail.com |
| Dr Yogendra Rai |
Homoeopathic Drug Research Institute(H) Lucknow |
Homoeopathic Drug Research Institute(H)Campus of National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH |
09873744361
raiyogendral@rediffmail.com |
| Dr Bhawan Singh |
Regional Research Institute (H) Guwahati |
Regional Research Institute (H)Rabha Bhawan Khalipara Odel Bakara Guwahati 781019
Kamrup
ASSAM |
08794252180
drbhawansingh@gmail.com |
| Dr Ojit Singh |
Regional Research Institute (H) Imphal |
Regional Research Institute(H)
New Checkon Maring Land Opp Trival Colony Imphal 795001
Imphal East
MANIPUR |
08974003895
drthojitsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Essential hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy with life style modification |
Individualized homoeopathy along with life style modification for 3 months |
| Comparator Agent |
Placebo with life style modifications |
Placebo with life style modifications for 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 30 to 60 yrs
2.Both genders
3.Essential hypertension of stage I (SBP 140-159; DBP 90-99)
4.Patients who were not on any anti-hypertensive medicine since last 1 month.
5.Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with secondary hypertension of any etiology.
2.Patients with pre hypertension, stage II hypertension as per JNC 7 criteria.
3.Known Diabetics.
4.Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect or known cases of cardiac diseases.
5.Patients with systemic illness
6.Patients receiving any drugs known to affect blood pressure
7.Patients judged to have a history of alcohol or drug abuse
8.Women who are taking contraceptive pills, pregnancy and lactating mother.
9.Patients suffering from hypothyroidism.
10.Unable or unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the mean change in systolic and diastolic blood pressure from baseline at every month for 3 months from baseline as per routine method.
2 To evaluate the changes in Ambulatory BP at 3rd month from baseline. |
every month for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percent of patients meeting the goal BP of SBP≤ 135mmHg and DBP ≤85 mmHg in patients of both the groups |
3 months |
|
|
Target Sample Size
|
Total Sample Size="217"
Sample Size from India="217"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="214" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/02/2014 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be a randomized double blind placebo controlled trial for a period of 3 months. Group 1: Individualized homoeopathy+ life style modifications (IH+LSM). Group 2: Control (life style modification- diet and exercise) Purpose of the study is to evaluate the mean changes in Stage I hypertensive patients with respect to systolic and diastolic BP in clinical setting. |