| CTRI Number |
CTRI/2025/09/094803 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Guatteria Gaumeri mother tincture and potency in the cases of Dyslipidemia |
|
Scientific Title of Study
|
A Randomised Parallel Arm
Clinical Trial To Assess The
Efficacy of Homoeopathic
Medicine Guatteria Gaumeri Q
Vis A Vis Centesimal Potency
In The Management of Cases
of Dyslipidemia |
| 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 Mayank Jethiwal |
| Designation |
PG Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Homoeopathic Pharmacy Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9887783003 |
| Fax |
|
| Email |
mayankjethiwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajraj Singh Rathore |
| Designation |
Professor and HOD |
| Affiliation |
Homoeopathy University |
| Address |
Department of Homoeopathic Pharmacy Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414362202 |
| Fax |
|
| Email |
gsrbachwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Jethiwal |
| Designation |
PG Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Homoeopathic Pharmacy Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9887783003 |
| Fax |
|
| Email |
mayankjethiwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homoeopathic Pharmacy Dr Girendra Pal Homoeopathic Hospital and Research Centre collegiate Hospital Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic medical college Hospital and Research Centre Jaipur |
| Address |
Saipura Sanganer Jaipur 302029 |
| Type of Sponsor |
Private medical college |
|
|
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 Mayank jethiwal |
Dr Girendra pal Homoeopathic Hospital and Research Centre Saipura Sanganer Jaipur |
Department of Homoeopathic Pharmacy OPD 8 Dr MPK Homoeopathic Medical College Hospital and Research Centre
A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
9887783003
mayankjethiwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guatteria Gaumeri Centesimal Potency |
All the eligible patient of Dyslipidemia based on Randomisation will be prescribed Guatteria Gaumeri Centesimal Potency as per the patient reassessment will be done after 3 month |
| Intervention |
Guatteria Gaumeri Mother Tincture |
All the eligible patient of Dyslipidemia based on Randomisation will be prescribed Guatteria Gaumeri Mother tincture and it is given orally dose based need of the patient reassessment will be done after 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Known case of Dyslipidemia without end organ damage
2 Patient giving consent and maintaining follow up
3 Male and female outpatients aged 20 years and above
4 Incidence of Hyperlipidemia with at least one of the following factors without end
organ damage
A Cholesterol level more than 200mg per dl
B TG level more than 150 mg per dl
C LDL C level higher than 130 mg per dl
D HDL C level less than 40 mg per dl
E Non HDL C more than 130 mg per dl |
|
| ExclusionCriteria |
| Details |
1 Patient with known case of coronary artery disease
2 Cannot follow therapeutic modification
3 Pregnant & lactating female
4 A recent add on of antilipidemic agents
5 History of CAD at an early age in the family less than 45yrs in males and in females less than 55 yrs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study the expectation that Guatteria Gaumeri mother tincture and its
centesimal potency when given will produce variation in patterns of lipid profile as well
as will be helpful in management of Dyslipidmia |
3 moths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study is expected to show the efficacy of Guatteria Gaumeri in cases of
Dyslipidemia when prescribed therapeutically and will help in faster management of
case |
12 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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
|
Aim
To compare the effectiveness of homoeopathic medicine
Guatteria gaumeri mother tincture vis a vis Guatteria Gaumeri centesimal
potency in the management of the cases of Dyslipidemia Objectives
1 To assess the effectiveness of homoeopathic medicine
Guatteria Gaumeri mother tincture vis a vis Guatteria gaumeri centesimal
potency in the management of the cases of Dyslipidemia
2 To assess the effectiveness of homoeopathic medicine
Guatteria gaumeri mother tincture for the management of cases of Dyslipidemia
3 To assess the effectiveness of homoeopathic medicine
Guatteria gaumeri centesimal potency for management the cases of Dyslipidemia
|