| CTRI Number |
CTRI/2012/02/002464 [Registered on: 28/02/2012] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Homeopathy in Controlling Essential Hypertension |
|
Scientific Title of Study
|
Exploring the Efficacy of Homoeopathy in Controlling Essential Hypertension: A Prospective Single-blind Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1343/MBHMCH/CH/H/01/11 |
Protocol Number |
| U1111-1128-2447 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
House Staff |
| Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
| Address |
93/2/1 Shibpur Road PO and PS Shibpur Howrah
Drainage Canal Road Doomurjala Howrah West Bengal Pin 711104
Haora
WEST BENGAL
711102
India |
| Phone |
09836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
House Staff |
| Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
| Address |
93/2/1 Shibpur Road PO and PS Shibpur Howrah
Drainage Canal Road Doomurjala Howrah West Bengal Pin 711104
Haora
WEST BENGAL
711102
India |
| Phone |
09836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
House Staff |
| Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
| Address |
93/2/1 Shibpur Road PO and PS Shibpur Howrah
Drainage Canal Road Doomurjala Howrah West Bengal Pin 711104
Haora
WEST BENGAL
711102
India |
| Phone |
09836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
| Address |
Drainage Canal Road Doomurjala Howrah West Bengal Pin 711104 India |
| Type of Sponsor |
Government medical college |
|
|
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 Subhranil Saha |
OPD and IPD of Mahesh Bhattacharyya Homeopathic Medical College & Hospital |
Drainage Canal Road Doomurjala
Haora
WEST BENGAL |
09836187425
drsubhranilsaha@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, Essential Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic medicines |
Intervention - 5 ml dose of Homeopathic medicine in 6/30/200/1M/10M/50M or 0/1 - 0/40 potency OD/BDS/TDS/QDS or as appropriate for 6 months. |
| Comparator Agent |
Placebo |
5 ml dose of rectified spirit in distilled water, identical in appearance of Homeopathic medicine OD for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 years and 75 years
2. Both sexes
3. Suffering from essential/primary hypertension for at least 6 months |
|
| ExclusionCriteria |
| Details |
1. Any continued anti-hypertensive therapy for at least 6 months
2. Malignant Hypertension with grave signs and symptoms as detected clinically
3. Patients suffering from isolated systolic hypertension
4. Patients not strictly conforming to the criteria given by JNC-7; variation of ±10 mm Hg in SBP/DBP considerable
5. Presence of severe concomitant disease(s)
6. Pregnancy, breast feeding and likelihood of pregnancy |
|
Method of Generating Random Sequence
Modification(s)
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in systolic blood pressure (SBP)
2. Reduction in diastolic blood pressure (DBP) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical improvement in symptom scores
2. Halt of the disease progress and complications
3. Prevention of relapse
3. Incidence of adverse events if any |
6 months |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/04/2011 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A single-center, prospective, participant blind, randomized, placebo-controlled, parallel group, interventional clinical trial was planned to enroll 132 participants (subjects 64, control 68) suffering from essential hypertension from April, 2011 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital. The aim of this trial was to evaluate the efficacy and/or safety of homeopathic medicines in reducing systolic and/or diastolic blood pressure measured at timeline of 6 months. Inclusion criteria include age between 18 and 75 years and both sexes and more than 6 months history of suffering from essential hypertension. Exclusion criteria include any continued anti-hypertensive therapy for at least 6 months, malignant Hypertension with grave signs and symptoms as detected clinically, patients suffering from isolated systolic hypertension. The protocol needed amendments and the study was terminated prematurely. |