| CTRI Number |
CTRI/2024/07/070649 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to measure effectiveness of individualized homoeopathic
management in cases of type-2 diabetes mellitus by observing changes in HbA1c lab reports. |
|
Scientific Title of Study
|
An empirical study on the effectiveness of individualized homoeopathic
management in cases of type-2 diabetes mellitus. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Kanubhai Roy |
| Designation |
Professor |
| Affiliation |
Parul University |
| Address |
Department of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University
Jawaharlal Nehru Homoeopathic Medical College, Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat 391760
Vadodara
GUJARAT
390019
India |
| Phone |
7405002111 |
| Fax |
|
| Email |
dr.mayankroy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heena Rawal |
| Designation |
Professor |
| Affiliation |
Parul University |
| Address |
Department of Homoeopathic Philosophy & Organon of Medicine, Ahmedabad Homeopathic Medical College
Bopal
Ahmedabad Homeopathic Medical College
Bopal - Ghuma Rd, Opposite Kabir Complex, South Bopal, Bopal, Ahmedabad, Gujara
Ahmadabad
GUJARAT
380058
India |
| Phone |
9427401176 |
| Fax |
|
| Email |
heena.rawalahmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Rawal |
| Designation |
Professor |
| Affiliation |
Parul University |
| Address |
Department of Homoeopathic Philosophy & Organon of Medicine, Ahmedabad Homeopathic Medical College, Bopal
Ahmedabad Homeopathic Medical College
Bopal - Ghuma Rd, Opposite Kabir Complex, South Bopal, Bopal, Ahmedabad, Gujara
Ahmadabad
GUJARAT
380058
India |
| Phone |
9427401176 |
| Fax |
|
| Email |
heena.rawalahmc@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College Hospital,Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Mayank Kanubhai Roy |
| Address |
C-15, indrapuri Soc. Near Bapod Jakat Naka Besides Vrundavan Hospital Waghodia Road, Vadodara
Pin Code - 390019 |
| 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 Mayank Roy |
Jawaharlal Nehru Homoeopathic Medical College Hospital |
Department of Organon of Medicine, JNHMC Hospital, Parul University, P.O.Limda, Ta.Waghodia, Dist. Vadodara, Vadodara, Gujarat 391760
Vadodara
GUJARAT |
7405002111
dr.mayankroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNHMC-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Mangement |
Individualized Homoeopathic Medicine, Centicimal or LM potency, in 40 size pills, orally administered at every week for OD or BSD
for atleast 3 month. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases pre-diagnosed or having clinical features of type 2 diabetes
mellitus.
2. The patients giving their consent to participate in study with minimum
six follow ups.
3. HbA1c level is 6.5% or Above
4. Age- 18 to 58 years and of both sexes.
5. Patients who are not taking any medication.
6. Patients who have stopped medication 3 moths before induction. |
|
| ExclusionCriteria |
| Details |
1. Age below 18 years and above 58 years.
2. Pregnant and lactating patients.
3. Patient with Serious complication with inflammatory changes.
4. Cases with less than 6 follow up.
5. Patient Diagnosed with G6PD deficiency (glucose-6-phosphatedehydrogenase
deficiency).
6. Any patient found to be uncooperative during the study.
7. Unable to Speak Gujarati, Hindi or English.
8. Patients on any other medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c change reduced to less than 6.5%. |
HbA1c at every 3 months in treatment duration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Lifestyle changes |
relief in symptoms at every 4 weeks. with changes in FBS & PP2BS at gradual pace. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/09/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 evaluate the effectiveness of Individualized Homoeopathic Management in cases of type 2 diabetes mellitus’. OBJECTIVES: 1) To assess how The Individualized Management of Type-2 Diabetes Mellitus patient can create wholistic changes. 2) To observe and evaluate the changes in the HbA1c as The Individualized Management works on patients with type 2 diabetes. H0 – Hypothesis "There is no significant difference in glycemic control among individuals with type 2 diabetes mellitus who receive individualized homeopathic management tailored to their unique symptoms and characteristics." Ha - Hypothesis "The application of individualized homeopathic management tailored to the unique symptoms and characteristics of each patient will lead to significant improvements in glycemic control in individuals with type 2 diabetes mellitus." |