| CTRI Number |
CTRI/2024/05/067276 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the comparison between Homoeopathic medicines and allium sativum mother tincture in high blood pressure patients. |
|
Scientific Title of Study
|
A randomized double arm parallel clinical study to compare the efficacy of individualized homoeopathic medicines adopting Kentian method of evaluation versus Allium Sativum mother tincture in management of essential hypertension. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Rai |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8851628585 |
| Fax |
|
| Email |
raianjali060@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Shankar Pal |
| Designation |
Professor |
| Affiliation |
State National homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7007015607 |
| Fax |
|
| Email |
drshivshankerpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Rai |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8851628585 |
| Fax |
|
| Email |
raianjali060@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department of State National homoeopathic Medical College and Hospital, 1-Viraj khand Gomti Nagar Lucknow Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Dr. Anjali Rai |
| Address |
State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow Uttar Pradesh-226010 |
| 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 |
| Dr Anjali Rai |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD No-10 of State National Homoeopathic Medical College and Hospital 1–viraj khand,gomti nagar, lucknow,uttar pradesh-226010
Lucknow
UTTAR PRADESH |
8851628585
raianjali060@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital Lucknow |
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 |
Allium Sativum Mother Tincture |
Allium Sativum Mother Tincture will be given to the group B patients selected on the basis of block randomization chart.Medicines will be dispensed from Pharmacy of State National Homoeopathic Medical College and Hospital.It will be administered to the patient in required doses depending upon the individual case. Route of administration will be oral.Each case will be followed up at regular interval as per requirement preferably at a period of 15 days upto minimum 6 months |
| Intervention |
Individualized Homoeopathic medicine |
Patients will be randomly divided into two groups A and B as per the computer generated block randomization chart. Individualized Homoeopathic medicine will be given adopting kentian method of evaluation to group A patients. Medicines will be dispensed from Pharmacy of State National Homoeopathic Medical College and Hospital.Medicine will be administered to the patient in required potency and doses depending upon the individual case.
Each case will be followed up at regular interval as per requirement preferably at a period of 15 days upto minimum 6 months.Route of administration will be oral. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from essential hypertension (stage I hypertension: SBP 140‑159 mmHg,DBP 90‑99 mm Hg)
2.Whose history,examination, and routine investigations revealed no evidence of
obvious secondary causes.
3.Patient who are willing for inclusion in the study and giving consent to participate and
willing for regular follow ups. |
|
| 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. Simultaneous participation in other clinical studies or completion of participation in a
study less than 6 months prior.
6. Patient on anti hypertensive medication.
7. Patient with autoimmune disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed by reduction in level of blood pressure. |
Every 15 days upto minimum 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF36 Questionnaire (By RAND) for quality of life assessment of essential hypertension patients. |
Every 4 weeks upto minimum 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hypertension is a major public health problem and important area of research due to its high prevalence and being major risk factors for cardiovascular diseases and other complications. This is a randomized , prospective ,double arm parallel open label study to compare the efficacy of individualized homoeopathic medicines adopting kentian method of evaluation and Allium Sativum Mother Tincture in management of Essential Hypertension . It will be conducted in State National Homoeopathic Medical College and Hospital. Outcome will be assessed on the basis of reduction in blood pressure and quality of life of patients will be assessed by using SF 36 Questionnaire every 4weeks. Duration of study is 18 months. |