| CTRI Number |
CTRI/2014/03/004478 [Registered on: 18/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
30/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in hypertension |
|
Scientific Title of Study
|
Individualized homoeopathy versus placebo in essential hypertension: a double-blind randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1343/MBHMCH/CH/H/01/11(A) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Central Council for Research in Homeopathy, Government of India |
| Address |
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Darjiling
WEST BENGAL
734006
India |
| Phone |
913532596065 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Central Council for Research in Homeopathy, Government of India |
| Address |
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Darjiling
WEST BENGAL
734006
India |
| Phone |
913532596065 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Senior Research Fellow |
| Affiliation |
Central Council for Research in Homeopathy, Government of India |
| Address |
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Clinical Research Unit (Homeopathy), Gokhel Road, Arabindapally
Darjiling
WEST BENGAL
734006
India |
| Phone |
913532596065 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College Hospital Government of West Bengal |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College Hospital Government of West Bengal |
| Address |
Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, 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 Nikhil Saha Principal inCharge |
Hypertension OPD: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, every Tuesday |
Drainage Canal Road, Doomurjala, Howrah 711104
Haora
WEST BENGAL |
03326774449
03326774449
principalmbhmch@gmail.com |
|
|
Details of Ethics Committee
|
| 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
|
| Health Type |
Condition |
| Patients |
Essential hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Single individualized
homeopathic remedy orally in
centesimal or 50 millesimal
potencies as appropriate. Each
dose in centesimal potency was
single drop of medicine
prepared in 88% dispensing
alcohol in 5 ml distilled water. In 50 millesimal potency, a single medicated globule number 10 dissolved in 50 ml distilled water with addition of 2 drops of 88%
dispensing alcohol, 10 doses
marked, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the bottle with hand on a firm surface in 45 ml water in a cup, to stir the mixture well, to take 5 ml of the mixture orally, and to discard rest of the liquid in cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the intensity of symptoms - total
duration of such intervention 6 months. |
| Comparator Agent |
Placebo |
Placebo indistinguishable from verum; identical in smell, taste and appearance; dispensed in similar manner to medicine;repetition 24, 12 or 8 hourly or even oftener - total duration of such intervention 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 years and 65 years
2. Both sexes
3. Suffering from essential/primary hypertension for at least 6 months
4. History, examination, and routine investigations revealed no evidence of obvious secondary causes
5. Giving written informed consent |
|
| 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 with labile hypertension
5. Patients with secondary hypertension
6. Patients not strictly conforming to the criteria given by JNC-7; variation of ±10 mm Hg in SBP/DBP considerable
7. Presence of severe concomitant infectious or systemic disease(s)or organ failure, psychiatric illness, developmental or congenital anomalies, and/or complications of hypertension
8. Pregnancy, breast feeding and likelihood of pregnancy
9. History of abuse and/or dependence on drugs and/or alcohol |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic and diastolic blood pressure |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving reduction in the two groups |
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is the most common cardiovascular
disorder posing a major public health challenge to the population. Homoeopathy,
although widely used in hypertension, is assumed to have nothing but placebo
effects and its specific clinical effects are frequently ascribed as
implausible. Aims were to evaluate whether individualized homoeopathy can
produce any significant effect different from placebo in essential hypertension
by comparing the lowering of blood pressure between groups. A prospective,
double-blind, randomized, placebo-controlled, parallel arm clinical trial was
conducted at the Outpatient Clinic of the Mahesh Bhattacharyya Homoeopathy
Medical College and Hospital, West Bengal. Out of 233 hypertensives assessed
for eligibility, 150 were enrolled and randomized (verum/homoeopathy 70,
control/placebo 80). A total of 18 dropped out and 132 were regular (verum 64,
control 68). The outcome measures were assessed after three months and six
months. The intention-to-treat population was subjected to statistical analysis. Group differences were tested using the χ2 test and
independent t test. Repeated measure (ANOVA) was performed to compare the data
of two groups obtained longitudinally at baseline, three months and six months.
The baseline data were not significantly different between the groups. After
six months, mean Systolic Blood Pressure (SBP) reduction was 26.6 mm Hg (95% CI
21.5, 31.7) in the homoeopathy group and SBP increased by 3.6 mm Hg (95% CI
8.7, 1.5) in the placebo group. Similarly, the mean Diastolic Blood Pressure
(SBP) in the homoeopathy group reduced by 11.8 mm Hg (95% CI 9.2, 14.4) and
increased by 1.6 mm Hg (95% CI 3.6, 0.4) in the placebo group. Repeated
measures ANOVA also showed significant difference (P=0.0001) between the
groups. Natrum muriaticum, Calcarea carbonica, Sulphur, Thuja occidentalis,
Nitric acid and Medorrhinum were frequently prescribed. Thus individualized
homoeopathy produced a significantly different hypotensive effect than placebo. |