| CTRI Number |
CTRI/2024/04/066570 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Interventional study with LM Potency on patients with grade 1 Hypertension |
|
Scientific Title of Study
|
Efficacy Of Homoeopathic Medicines Using LM Potency in Management Of Essential Hypertension(Grade 1) in Patients having Body Mass Index 25-35 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrArfana Chauhan |
| Designation |
PG scholar |
| Affiliation |
Smt A J Savla Homoepathic Medical college and Research Institute |
| Address |
Room no 10
Department of Medicine
Ground floor
Smt A J Savla Homoeopathic Medical college and Research Institute
Pushapnjali Building
Near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7041637799 |
| Fax |
|
| Email |
chauhan.arfana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnand Desai |
| Designation |
Professor PG Department of Organon of Medicine and Homoeopathic philosophy |
| Affiliation |
Smt A J Savla Homoepathic Medical college and Research Institute |
| Address |
Room no 10
Department of Medicine
ground floor
Smt A J Savla Homoeopathic Medical college and Research Institute
Pushapnjali Building
Near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9979885148 |
| Fax |
|
| Email |
dranandjvb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrArfana Chauhan |
| Designation |
PG scholar |
| Affiliation |
Smt A J Savla Homoepathic Medical college and Research Institute |
| Address |
Room no 10
Department of Medicine
Ground floor
Smt A J Savla Homoeopathic Medical college and Research Institute
Pushapnjali Building
Near district session court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7041637799 |
| Fax |
|
| Email |
chauhan.arfana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical college and Research Institute
Pushpanjali Building
Near District Session Court
Mehsana
Gujarat
384001
|
|
|
Primary Sponsor
|
| Name |
DrArfana Chauhan |
| Address |
Room no 10
Department of Medicine
Ground floor
Smt A J Savla Homoeopathic Medical college and Research Institute
Pushpanjali Building
Near District Session Court
Mehsana Gujarat
384001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrArfana Chauhan |
Smt A J Savla Homoeopathic Medical college and Research Institute |
Room No 10
Department Of Medicine
Ground Floor
Pushpanjali Building
Near District Session Court
Mehsana
Mahesana
GUJARAT |
7041637799
chauhan.arfana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic medical college institutional ethical 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 |
| Intervention |
Medicine In LM potency |
Potency LM Potency
Dose as per the criteria of LM Potency
Medicine will dispensed as per the criteria of LM potency
Frequency as per need of case
route of administration oral route
Duration of therapy up to 8 months as per need of case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Participants must have a confirmed diagnosis of essential hypertension as per established medical criteria
Participants with baseline Systolic Blood Pressure
more than 120 to 159 and Diastolic Blood Pressure more than 80 to 99 who are not on any anti hypertensive medicines
Participants with a body mass index of 25 to 35
Participants willing to provide informed consent to participate in the study and also who can fill up the Questionnaire |
|
| ExclusionCriteria |
| Details |
Patients who are suffering from secondary Hypertension of known aetiology such as renal disease pheochromocytoma or Cushing’s syndrome known diabetics, history of myocardial infarction severe coronary artery disease or clinically significant heart failure or valvular defect or known cases of cardiac diseases any systemic illness consumptive disease autoimmune disease cancer hepatic disease renal disease
Patients receiving any drugs known to affect Blood Pressure or medical treatments that can influence the Blood Pressure having a history of alcohol or drug abuse
Women who are taking contraceptive pills pregnancy and lactating mother
Patients having class 2 and class 3 obesity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the blood pressure both systolic and diastolic |
data will be assessed from baseline 2 4 6 8 months and changes in the blood pressure will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in the Minichal Questinnorie score |
from baseline to at the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective pre test post test interventional trial to assess the efficacy of Homoeopathic medicines in LM potency in 40 participants of grade 1 hypertension BMI 25-35 as per the inclusion criteria and exclusion criteria from OPD The Primary outcome will assess the changes in Blood pressure after giving Individual Homoeopathic medicines in LM potency at 2 4 6 8 months. Secondary outcome will assess changes in MINICHAL Questionnarie after giving Individual Homoeopathic medicines in LM potency from baseline and at the end of treatment . |