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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  
Status 
Not Applicable 
 
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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