| CTRI Number |
CTRI/2019/10/021507 [Registered on: 01/10/2019] Trial Registered Prospectively |
| Last Modified On: |
26/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effect of individualised homoeopathic medicine (similimum) on modifying the anger of patients having mild to moderate essential hypertension and thereby reducing the raised blood pressure against standard antihypertensive treatment
|
|
Scientific Title of Study
|
A double-blind, placebo controlled, randomised trial using individualised homoeopathic treatment for modifying anger and thereby reducing blood pressure in patients of essential hypertension against standard care treatment |
| Trial Acronym |
MAEHT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr LEENA BAGADIA |
| Designation |
PhD scholar - Principal investigator |
| Affiliation |
Dr.M.L.Dhawale Memorial Homoeopathic Institute and Hospital |
| Address |
2, Palm Springs society, Mukteshwar Devalay Marg, Near Chandan cinema, Juhu Department of Homoeopathic psychiatry
Palghar Mumbai (Suburban) MAHARASHTRA 400049 India |
| Phone |
09870098982 |
| Fax |
|
| Email |
leenabagadia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr LEENA BAGADIA |
| Designation |
PhD scholar - Principal investigator |
| Affiliation |
Dr.M.L.Dhawale Memorial Homoeopathic Institute and Hospital |
| Address |
2, Palm Springs society, Mukteshwar Devalay Marg, Near Chandan cinema, Juhu Department of psychiatry
Palghar Mumbai (Suburban) MAHARASHTRA 400049 India |
| Phone |
09870098982 |
| Fax |
|
| Email |
leenabagadia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr LEENA BAGADIA |
| Designation |
PhD scholar - Principal investigator |
| Affiliation |
Dr.M.L.Dhawale Memorial Homoeopathic Institute and Hospital |
| Address |
2, Palm Springs society, Mukteshwar Devalay Marg, Near Chandan cinema, Juhu Department of psychiatry
Palghar Mumbai (Suburban) MAHARASHTRA 400049 India |
| Phone |
09870098982 |
| Fax |
|
| Email |
leenabagadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Health Progress Trust
DrLeena Bagadia |
|
|
Primary Sponsor
|
| Name |
DrLeena Bagadia |
| Address |
2, Palm Springs Society, Mukteshwar Devalay Marg, Juhu, Mumbai - 49 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rural Health Progress Trust |
RHPT, In front of SBI, Murud, Dist. - LaturOsmanabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Leena Bagadia |
Rural Health Progress Trust |
At Bhikar Sarola
Post Palsap, Tq Dist Osmanabad
Maharashtra 413510 Osmanabad MAHARASHTRA |
09870098982
leenabagadia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
placebo (Sugar of milk globules |
sugar of milk globules without adding homoeopathic medicine liquid
|
| Intervention |
Individualised homoeopathic remedy |
be done and individualised homoeopathic remedy will be prescribed depending on the totality of symptoms It will be administered in the form of medicine liquid added a drop on sugar of milk powder and/ or pills, administered orally. Pills (which may or may not contain medicinal substance) will be 4 pills 3 times a day and powder 2-3 times a week or as per requirement. Therapy is continued for 6-month study period and later if required, can be continued.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of essential hypertension |
|
| ExclusionCriteria |
| Details |
Patients having secondary hypertension
Pregnant and lactating women
Uncontrolled endocrine disorders
Severe psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in anger variables scores
Changes in blood pressure values |
At the end of 6 months study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the intensity of comorbid conditions |
Follow up every 2 weeks to assess subjective and objective criteria |
|
|
Target Sample Size
|
Total Sample Size="350" Sample Size from India="350"
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)
|
01/11/2019 |
| 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="2" Months="0" 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
|
BACKGROUND Hypertension constitutes an important public health issue. It affects 30% of world population according to the latest data. The aetiology of hypertension is various and complex, involving both genetic and behavioural factors. More and more people experience increased anger, anxiety, depression brought on by globalization, cultural changes, socioeconomic changes, and stress at workplace. The effects of anger & hostility on blood pressure are in the focus of researchers for many years. Aside from the intrinsic psychophysiological interest of these effects, this research is also motivated by the possibility that blood pressure may positively correlate with the variables of anger and hostility and thus the risk of hypertension and other cardiovascular diseases would increase. AIM To demonstrate the efficacy of the homoeopathic similimum on mild to moderate essential hypertension (EHT) by modifying the underlying anger state – trait and expressions, thus making the patient more capable to cope with the changing life situations as compared to placebo. OBJECTIVES 1. Identifying the anger state – trait and expressions and quantify them with the help of State – Trait Anger Expression Inventory – 2 (STAXI2) in patients having essential hypertension. 2. Correlating the anger state – trait and expressions with systolic and diastolic blood pressure levels. 3. Evaluating the efficacy of homoeopathic similimum on patients with mild to moderate essential hypertension in modifying the underlying anger state – trait and expressions. 4. To study the safety of homoeopathic similimum in patients with mild to moderate essential hypertension in modifying the underlying anger state, trait and expression. HYPOTHESE: 1. The group of patients that gets the homoeopathic similimum for anger will have better blood pressure control than the group on placebo. 2. There is positive relationship between components of anger and hypertension. 3. Individualised homoeopathic treatment is more effective in reducing anger and thereby controlling hypertension than standard antihypertensives. 4. There is no difference in the rate of complication in both the groups. 5. Children of hypertension patients are more prone to hyper-react to stressors and thereby more susceptible to hypertension. 6. EHT can be improved by better anger coping mechanism.
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