| CTRI Number |
CTRI/2025/09/094484 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study of how Homoeopathic Mother Tinctures as add on treatment help Adults with Insulin Resistance measured by TyG-BMI Index |
|
Scientific Title of Study
|
EFFECTIVENESS OF HOMOEOPATHIC MOTHER TINCTURES AS ADD-ON THERAPY IN ADULTS SCREENED FOR INSULIN RESISTANCE BY TyG-BMI INDEX: AN OPEN-LABEL RANDOMIZED TRIAL |
| 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 PARIDHI JAIN |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE
10, 11 AND 12, WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029
ROOM NO 6, Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL
VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN
302029
India |
| Phone |
9314036433 |
| Fax |
|
| Email |
paridhij6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHANDRA SHEKHAR SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE
10, 11 AND 12, WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029
ROOM NO 6, Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL
VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN
302029
India |
| Phone |
9314539277 |
| Fax |
|
| Email |
drcssharma.jaipur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PARIDHI JAIN |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE
10, 11 AND 12, WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029
ROOM NO 6, Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL
VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN
302029
India |
| Phone |
9314036433 |
| Fax |
|
| Email |
paridhij6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr GIRENDRA PAL HOMOEOPATHIC HOSPITAL AND RESEARCH CENTRE COLLEGIATE HOSPITAL OF Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE
A CONSTITUENT COLLEGE OF HOMOEOPATHY UNIVERSITY, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029 |
| Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL, VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001 |
|
|
Primary Sponsor
|
| Name |
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
10,11 AND 12, WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PARIDHI JAIN |
Dr GIRENDRA PAL HOMOEOPATHIC HOSPITAL AND RESEARCH CENTRE |
UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE
10, 11 AND 12, WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029
Jaipur
RAJASTHAN |
9314036433
paridhij6@gmail.com |
| Dr PARIDHI JAIN |
Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL |
ROOM NO 6
VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN |
9314036433
paridhij6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE PLUS BERBERIS VULGARIS MOTHER TINCTURE |
THE DOSE AND REPETITION OF MEDICINES, INCLUDING MOTHER TINCTURES, MAY VARY ACCORDING TO THE SUSCEPTIBILITY AND SENSITIVITY OF THE PATIENT, THE ACUTE OR CHRONIC NATURE OF THE DISEASE AND THE AGE AND VITALITY OF THE INDIVIDUAL.
IN THIS TRIAL, DOSAGE, REPETITION AND DISPENSING (IN THE FORM OF GLOBULES NO. 40) OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE WILL BE AS PER THE NEED OF THE CASE AND THE GUIDELINES OF THE ORGANON OF MEDICINE.
THE SELECTED DOSE OF MOTHER TINCTURES (approx. 20 to 50 DROPS) REPRESENTS A MINIMUM, SAFE AND STANDARDIZED RANGE. THE DOSE AND REPETITION WILL BE DETERMINED ACCORDING TO THE NEED OF THE CASE AND PREVIOUS RESEARCH EVIDENCES. REASSESSMENT WILL BE DONE AT THE END OF 3 MONTHS, WITH ALL INTERVENTIONS CLOSELY MONITORED FOR SAFETY THROUGHOUT THE STUDY. |
| Comparator Agent |
INDIVIDUALISED HOMOEOPATHIC MEDICINE |
THE DOSE AND REPETITION OF MEDICINES MAY VARY ACCORDING TO THE SUSCEPTIBILITY AND SENSITIVITY OF THE PATIENT, THE ACUTE OR CHRONIC NATURE OF THE DISEASE AND THE AGE AND VITALITY OF THE INDIVIDUAL. IN THIS TRIAL, DOSAGE, REPETITION AND DISPENSING (IN THE FORM OF GLOBULES NO. 40) WILL BE AS PER THE NEED OF THE CASE AND THE GUIDELINES OF THE ORGANON OF MEDICINE. REASSESSMENT WILL BE DONE AT THE END OF 3 MONTHS. |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE PLUS CRATAEGUS OXYACANTHA MOTHER TINCTURE |
THE DOSE AND REPETITION OF MEDICINES, INCLUDING MOTHER TINCTURES, MAY VARY ACCORDING TO THE SUSCEPTIBILITY AND SENSITIVITY OF THE PATIENT, THE ACUTE OR CHRONIC NATURE OF THE DISEASE AND THE AGE AND VITALITY OF THE INDIVIDUAL.
IN THIS TRIAL, DOSAGE, REPETITION AND DISPENSING (IN THE FORM OF GLOBULES NO. 40) OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE WILL BE AS PER THE NEED OF THE CASE AND THE GUIDELINES OF THE ORGANON OF MEDICINE.
THE SELECTED DOSE OF MOTHER TINCTURES (approx. 20 to 50 DROPS) REPRESENTS A MINIMUM, SAFE AND STANDARDIZED RANGE. THE DOSE AND REPETITION WILL BE DETERMINED ACCORDING TO THE NEED OF THE CASE AND PREVIOUS RESEARCH EVIDENCES. REASSESSMENT WILL BE DONE AT THE END OF 3 MONTHS, WITH ALL INTERVENTIONS CLOSELY MONITORED FOR SAFETY THROUGHOUT THE STUDY. |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE PLUS CRATAEGUS OXYACANTHA PLUS BERBERIS VULGARIS MOTHER TINCTURES |
THE DOSE AND REPETITION OF MEDICINES, INCLUDING MOTHER TINCTURES, MAY VARY ACCORDING TO THE SUSCEPTIBILITY AND SENSITIVITY OF THE PATIENT, THE ACUTE OR CHRONIC NATURE OF THE DISEASE AND THE AGE AND VITALITY OF THE INDIVIDUAL.
IN THIS TRIAL, DOSAGE, REPETITION AND DISPENSING (IN THE FORM OF GLOBULES NO. 40) OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE WILL BE AS PER THE NEED OF THE CASE AND THE GUIDELINES OF THE ORGANON OF MEDICINE.
THE SELECTED DOSE OF MOTHER TINCTURES (approx. 20 to 50 DROPS) REPRESENTS A MINIMUM, SAFE AND STANDARDIZED RANGE. THE DOSE AND REPETITION WILL BE DETERMINED ACCORDING TO THE NEED OF THE CASE AND PREVIOUS RESEARCH EVIDENCES. REASSESSMENT WILL BE DONE AT THE END OF 3 MONTHS, WITH ALL INTERVENTIONS CLOSELY MONITORED FOR SAFETY THROUGHOUT THE STUDY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide informed written consent.
2. BMI more than or equals to 23 kg per m2
3. Impaired fasting plasma glucose more than or equals to 100mg per dl or PP(2h) and blood glucose random more than or equals to 140mg per dl or HbA1c more than or equals to 5.7 percent
4. Impaired fasting triglycerides more than or equals to 150mg per dl
5. Blood pressure more than or equals to 140 over 90 mm of Hg
6. Diagnosed with insulin resistance, defined by elevated TyG-BMI index (based on TyG-BMI Quartiles).
7. Those already taking medications that directly alter insulin resistance (e.g., metformin, pioglitazone, statins, corticosteroids, weight-loss drugs) still TyG-BMI index is high.
8. Willing and able to comply with treatment, follow-up visits, and protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to provide informed written consent or unable to follow up regularly or comply with the protocol.
2. Patients with clinically unstable or advanced organ diseases.
3. Pregnant or lactating women, due to hormonal effects and ethical limitations.
4. Patients with acute infections, ongoing febrile illnesses, or current hospitalization.
5. Individuals with substance abuse, severe psychiatric illness, or cognitive impairment affecting compliance.
6. Known allergy to Crataegus or Berberis preparations.
7. Participants enrolled in any other clinical trial. |
|
|
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 |
| PARTICIPANTS RECEIVING HOMOEOPATHIC MOTHER TINCTURES ALONG WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINES ARE EXPECTED TO SHOW A GREATER REDUCTION IN TYG-BMI INDEX COMPARED TO THOSE RECEIVING INDIVIDUALIZED HOMOEOPATHIC TREATMENT ALONE |
PRE- AND POST-SCORES WILL BE ASSESSED BASED ON ALTERATIONS IN TYG-BMI VALUES ACROSS QUARTILES (Q1–Q4) AT THE END OF 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AT THE END OF STUDY WE EXPECT THAT CRATAEGUS OXYACANTHA AND BERBERIS VULGARIS HOMOEOPATHIC MOTHER TINCTURES NOT ONLY MANAGED INSULIN RESISTANCE BUT ALSO ITS COMORBIDITIES |
12 MONTHS |
| MOTHER TINCTURE DOSES ARE EMPIRICALLY DERIVED AND NOT YET RIGOROUSLY VALIDATED; THEREFORE, THIS STUDY WILL CONTRIBUTE TOWARD DOSE VALIDATION. THE TRIAL IS EXPECTED TO GENERATE DATA TO SUPPORT FUTURE DOSE–RESPONSE EVALUATIONS AND FACILITATE EVIDENCE-BASED REFINEMENT OF MOTHER TINCTURE USE IN HOMOEOPATHY AS AN ADD-ON THERAPY. |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
21/09/2025 |
| 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="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 ascertain the effectiveness of Homoeopathic mother tinctures (Crataegus oxyacantha and Berberis vulgaris) when given along with individualised medicine in altering the parameter of TyG-BMI index in adults screened for insulin resistance.
OBJECTIVES 1. To assess the effectiveness of Homoeopathic individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance. 2. To assess the effectiveness of Homoeopathic mother tincture Crategus oxycantha when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance. 3. To assess the effectiveness of Homoeopathic mother tincture Berberis vulgaris when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance. 4. To assess and compare the effectiveness of Homoeopathic mother tinctures (Crataegus oxyacantha and Berberis vulgaris) when given along with individualised medicine by comparing pre and post reports of TyG-BMI index in adults screened for insulin resistance.
JUSTIFICATION OF STUDY Given the rising global and national burden of insulin resistance (IR) and its progression to chronic conditions such as type 2 diabetes, cardiovascular disease, and MASLD, there is an urgent need to explore safe, accessible, and cost-effective adjunctive therapies. Homoeopathic mother tinctures, particularly Crataegus oxyacantha and Berberis vulgaris, have shown promising lipid-modulating and insulin-sensitizing effects in previous studies, but their efficacy in Insulin Resistance (IR) using validated endpoints like the TyG-BMI index remains underexplored. This study addresses a key research gap by being among the first randomized controlled trials to evaluate the impact of these mother tinctures on TyG-BMI levels in individuals with insulin resistance. It leverages TyG-BMI as a practical, non-invasive screening and monitoring tool suitable for primary care and low-resource settings. If effective, these remedies could offer a well-tolerated and integrative approach to improving insulin sensitivity, with minimal adverse effects and greater patient compliance. By combining individualized constitutional homoeopathy with organ-targeted mother tinctures, this study aligns with the growing global interest in complementary and alternative medicine (CAM). It aims to generate evidence-based support for the inclusion of homoeopathic interventions in metabolic care, ultimately contributing to early intervention, enhanced patient outcomes, and holistic disease management. |