| CTRI Number |
CTRI/2021/06/034396 [Registered on: 25/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study homoeopathic management of stress in essential hypertension patients in age group of 35-80 years. |
|
Scientific Title of Study
|
Role of homoeopathic medicines in management of stress in essential hypertension patients in the age group of 35-80 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Barkha Dipak Patil |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, Pune. |
| Address |
Practice of Medicine Department, Bharati Vidyapeeth ( Deemed to be University) Homoeopathic Medical College and Hospital and Research Centre
Bharati Vidyapeeth Educational Campus, Pune - Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8511358402 |
| Fax |
|
| Email |
barkhapatil123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrinal Ashish Nerlekar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, Pune. |
| Address |
Practice of Medicine Department, Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital and Research Centre.
Bharati Vidyapeeth Educational Campus, Pune - Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
mrinalnerlekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrinal Ashish Nerlekar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, Pune. |
| Address |
Practice of Medicine Department, Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital and Research Centre
Bharati Vidyapeeth Educational Campus, Pune - Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
mrinalnerlekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University Homoeopathic medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Barkha Dipak Patil |
Bharati Vidyapeeth Homoeopathic Medical College and Hospital |
Practice Of Medicine Department
Pune
MAHARASHTRA |
8511358402
barkhapatil123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Homoeopathic Medical College and Hospital |
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 |
| Intervention |
Individualized homoeopathic medicine |
1. Potency and dose will be according to laws of posology and requirement of the case potency will be 30, 200, 1M, 10M.
2. oral route. first dose will be given in powder (lactose) form in front of physician in the required potency based on laws of posology. SL will be given for the remaining days until the next follow up which will be at an interval of 15 days. Repetition of dose will be done as per the need of the patient.
3. Time of action of medicine will be taken into account while deciding on frequency of repetition of dose. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes & age group between 35-80 yrs.
2. Patients presenting with pre-diagnosed mild to moderate essential hypertension without any major systemic complications whose exciting or maintaining cause of essential hypertension is identified to be stress.
3. Patients on allopathic treatment for essential hypertension fulfilling above two inclusion criterias will be enrolled.
4. Patients on no allopathic or no homoeopathic treatment (from other doctors for essential hypertension treatment) fulfilling the first
two inclusion criterias will be enrolled.
5. The ability to give informed consent & comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women with essential hypertension.
2. Patients with severe essential hypertension.
3. Patients with secondary hypertension.
4. Patients who require emergency medical interventions or Severe co-morbidities.
5. Patients on homoeopathic treatment for essential hypertension from another doctor will be excluded.
6. Simultaneous participation in other clinical studies or completion of participation in a study less than 6 months prior (patients are to
be explicitly asked about this).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment BEFORE and AFTER the study.
2. Improvement in SF36 (by RAND) used for Quality of life assessment of the essential hypertension patients BEFORE and AFTER the study. |
1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment at baseline and after 3 months.
2. Improvement in SF36 (by RAND) used for Quality of life assessment of the essential hypertension patients at baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in essential hypertension assessed by reduction in levels of blood pressure after 3 months of treatment. |
Changes in levels of blood pressure at baseline and after 3 months of treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
30/06/2021 |
| 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)
|
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)?
Response - NO
|
|
Brief Summary
|
Use of homeopathic remedies in the treatment of HTN is proved effective clinically, but more scientific researches need to be done. Managing an individual having HTN with homeopathic drugs is an art. In case of primary/essential HTN, homeopathy is concerned with the patient having high blood pressure rather than the hypertension itself. It is the sick man who has to restore to health, not his tissues, not his body. It is the constitutional makeup (inherited or acquired) of an individual and the environmental influences (internal or external) that predispose a person to develop HTN. Most patients associated stress as the cause for hypertension. There are many medicines in various ,material medicas which have indications that they could be useful in stress management of essential hypertension patients. Hence I want to conduct this study to assess the role of homoeopathic medicines in reducing stress and in the effectiveness of treatment of essential hypertension patients.
Aim and Objective of the Study : AIM : To evaluate role of homoeopathic medicines in management of stress in treatment of essential hypertension patients and see its effect on levels of blood pressure.
Primary objective : 1. To reduce stress of mild to moderate essential hypertension patients and see its effect on levels of blood pressure.
Secondary objectives : 1. To analyse the role of homoeopathic medicines in management of stress in essential hypertension patients. 2. To see effect of stress reduction on levels of blood pressure. 3. To assess the stress levels before and after the treatment. 4. To assess quality of life of patients before and after the treatment.
HYPOTHESIS : Null hypothesis Homoeopathic medicines have no significant effect in reducing stress of essential hypertension patients and in the management of their elevated blood pressure levels. |