| CTRI Number |
CTRI/2025/09/094302 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Allium sativum in different potency scales in the management of dyslipidemia |
|
Scientific Title of Study
|
Effectiveness Of Allium sativum in Centesimal And Decimal Potency in the Management Of Dyslipidemia In Adults; A Randomised Comparative Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farah |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
F 14 Department of Pharmacy floor no 1 Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9773738179 |
| Fax |
|
| Email |
farahbhms11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rumjhum Singh |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
F 14 Department of Pharmacy floor no 1 Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9868105521 |
| Fax |
|
| Email |
rumjhumsingh1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Ambwani |
| Designation |
Professor and HOD |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
F 14 Department of Pharmacy floor no 1 Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8130804123 |
| Fax |
|
| Email |
ambwani.drmeenakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 210310 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 22 Principal office Ground Floor 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Farah |
Bakson Homoeopathic Medical College and Hospital |
OPD Room no 1 Ground floor Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9773738179
farahbhms11@gmail.com |
| Farah |
Dr. D P Rastogi Central Research Institute Homoeopathy |
Opd no 110, ground floor A-1/1 opp. HCL Sector 24, Noida Uttar Pradesh 201307
Gautam Buddha Nagar
UTTAR PRADESH |
9773738179
farahbhms11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee.Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kedriya homoeopathy anusandhan parishad |
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 |
| Intervention |
Allium sativum in centesimal scale |
Oral route of administration 30 Pill size globule 5 medicated globules orally once daily for fifteen days and then 5 globules of placebo once daily up till next follow up centesimal scale potency First dose after case taking Repetition of doses according to follow ups which is every month |
| Intervention |
Allium sativum in decimal scale |
Oral route of administration
30 Pill size globule 5 medicated globules orally once daily for fifteen days and then 5 globules of placebo once daily up till next follow up
Decimal scale potency
First dose after case taking
Repetition of doses according to follow ups which is every month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed and confirmed cases of dyslipidemia
Participants with lipid levels within the following ranges based on NCEP ATP III guidelines Total Cholesterol between 200 and 300 mg/dL LDL Cholesterol between 130 and 189 mg/dL Triglycerides between 150 and 400 mg/dL and HDL Cholesterol less than 40 mg/dL
Participants who willing participate will provide written consent and comply with Allium sativum treatment and lipid monitoring
Participants with BMI in the following ranges Normal 18.5 to 24.9 kg/m² Overweight 25.0 to29.9 kg/m² and Class I Obese 30.0 to 34.9 kg/m² |
|
| ExclusionCriteria |
| Details |
Individuals with uncontrolled hypertension or poorly managed diabetes
Participants with Class II obesity with BMI 35.0 to 39.9 kg/m² and Class III with BMI more than equal to 40.0 kg/m²
Those with severe systemic illnesses or immunocompromised states
Individuals with severe psychiatric disorders that may impair consent or adherence
Pregnant or lactating women
Fasting triglyceride levels more than 400 mg/dL
Known allergy or hypersensitivity to Allium sativum that is garlic
Participants currently using statins blood thinners or steroidal medications
Active alcohol or tobacco users
Participants taking any form of steroidal treatment in last 3 months
Participants having vitiligo asthma atopic dermatitis psoriasis systemic lupus erythematous and any localized traumatic history |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Allium sativum in centesimal and decimal potency in dyslipidemia via changes in lipid profile ranges |
16 months study
6 months enrollment
6 months follow up
4 month data analysis and report writing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/09/2025 |
| 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="4"
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
|
Role of Allium sativum in centesimal and decimal scale in dyslipidemia via randomisation to see which potency will work better in managing the cases of dyslipidemia in adult age group.Group A will be given centesimal potency and Group B will be given decimal potency and each group will have 35 participant. Will test the outcome via lipid profile ranges. |