| CTRI Number |
CTRI/2025/08/093312 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing lycopus virginicus 30C and individualized homoeopathic treatment for managing early stage high blood pressure in adults-A study with a placebo group |
|
Scientific Title of Study
|
A three arm placebo controlled trial to evaluate efficacy of lycopus virginicus 30C versus constitutional remedy in the management of stage 1 essential hypertension in adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupal Shrimal |
| Designation |
Post graduate resident |
| Affiliation |
Swasthya kalyan homoeopathic medical college and research centre |
| Address |
OPD Number 29 and 30 general medicine
Swathaya kalyan homoeopathic medical college and research centre 10-A sitapura institutional area sitapura tonk road jaipur
Swasthya kalyan homoeopathic medical college and research centre 10-A sitapura institutional area sitapura tonk road jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7727934924 |
| Fax |
|
| Email |
Rupalshrimalrup@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShuchita chattree |
| Designation |
Professor |
| Affiliation |
Swasthya kalyan homoeopathic medical college and research centre |
| Address |
Swasthya kalyan homoeopathic medical college and research centre
10-A sitapura institutional area sitapura tonk road jaipur
Swasthya kalyan homoeopathic medical college and research centre
10-A sitapura institutional area sitapura tonk road jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9828059920 |
| Fax |
|
| Email |
shuchita.chattree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShuchita chattree |
| Designation |
Professor |
| Affiliation |
Swasthya kalyan homoeopathic medical college and research centre |
| Address |
Swasthya kalyan homoeopathic medical college and research centre
10-A sitapura institutional area sitapura tonk road jaipur
Swasthya kalyan homoeopathic medical college and research centre
10-A sitapura institutional area sitapura tonk road jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9828059920 |
| Fax |
|
| Email |
shuchita.chattree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya kalyan homoeopathic medical college and research centre 10-A sitapura institutional area sitapura tonk road jaipur |
|
|
Primary Sponsor
|
| Name |
Swasthya kalyan homoeopathic medical college and research centre |
| Address |
Swasthya kalyan homoeopathic medical college and research centre
10-A sitapura institutional area sitapura tonk road jaipur
pincode-302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rupal Shrimal |
Swasthya kalyan homoeopathic medical college and research centre |
Swasthya kalyan homoeopathic medical college and research centre 10-A sitapura institutional area sitapura tonk road jaipur
Jaipur
RAJASTHAN |
07727934924
Rupalshrimalrup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya kalyan homoeopathic medical college 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 |
| Intervention |
Constitutional remedy |
4-6 globules, globule no.30, route of administration-mouth/sublinguial, potency will be based on susceptibility of patient and doses will be given following homoeopathic principles, repetition according to homoeopathic principles for 3 months |
| Intervention |
Lycopus virginicus 30C |
4-6 globules, globule no.30, route of administration-mouth/sublinguial, initially thrice a day after first follow up repetition will be done as per assessing the condition of the patient in each follow up for 3 months |
| Comparator Agent |
Placebo control group |
4-6 globules , globule no.30, route of administration-mouth/sublinguial, placebo 30 thrice a day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed cases or new patient fulfilling diagnostic criteria.
Diagnosed with Stage 1 Essential Hypertension as per JNC-8 criteria.
Patient who has given written consent.
Not on any anti-hypertensive medicines.
|
|
| ExclusionCriteria |
| Details |
Stage 2 hypertension, Secondary hypertension.
Cases with major complications and end organs involvement.
Pregnant
Lactating women
Psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment done on pre and post values of systolic blood pressure and diastolic blood pressure |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To formulate the lycopus virginicus 30C and constitutional remedy profile for management of stage 1 essential hypertension |
12 months |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
30/08/2025 |
| 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
|
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 interventional, prospective ,randomized ,three parallel arm placebo control, single blind study to evaluate the efficacy of lycopus virginicus 30C versus constitutional remedy in the management of stage 1 essential hypertension in adults. The study will conducted at Swasthya kalyan homoeopathic medical college and research centre, jaipur .The primary outcome measures on the basis of pre and post values of systolic and diastolic blood pressure ,regular follow up assessment. It will be conducted for 1 year. The objectives are to compare the efficacy of lycopus virginicus 30C in the management of stage 1 essential hypertension with placebo control group ,to compare the efficacy of constitutional remedy in the management of stage 1 essential hypertension with placebo control group and to compare the efficacy of lycopus virginicus 30C versus constitutional remedy in the management of stage 1 essential hypertension with placebo control group |