| CTRI Number |
CTRI/2025/03/081505 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Managing sugar Disease with homoeopathic medicine. |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of homoeopathic medicine acid phosphoricum 30 c potency versus acid phosphoricum mother tincture in management of diabetes mellitus type 2 |
| 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 NiteshKumar M Babariya |
| Designation |
Phd Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room no 5, 3rd floor, Department of Materia Medica (Phd), Rajkot homoeopathic medical College, makkam chowk, bhakti Nagar,rajkot, Gujarat,India Pincode-360002
Rajkot
GUJARAT
360002
India |
| Phone |
9737152471 |
| Fax |
|
| Email |
niteshbabariya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Dubey |
| Designation |
Professor Materia Medica Department, Rajkot Homoeopathic Medical College |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room no 5, 3rd floor, Department of Materia Medica (Phd), Rajkot homoeopathic medical College, makkam chowk, bhakti Nagar,rajkot, Gujarat,India Pincode-360002
Rajkot
GUJARAT
360002
India |
| Phone |
9882244568 |
| Fax |
|
| Email |
doctorankit79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Babariya |
| Designation |
PhD Scholar Rajkot Homoeopathic medical college |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room no 5, 3rd floor, Department of Materia Medica (Phd), Rajkot homoeopathic medical College, makkam chowk, bhakti Nagar,rajkot, Gujarat,India Pincode-360002
Rajkot
GUJARAT
360002
India |
| Phone |
9882244568 |
| Fax |
|
| Email |
niteshbabariya19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr NiteshKumar M Babariya |
| Address |
Room no 5, 3rd floor, Department of Materia Medica (Phd), Rajkot homoeopathic medical College, makkam chowk, bhakti Nagar,rajkot, Gujarat,India Pincode-360002 |
| 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 NiteshKumar M Babariya |
Rajkot Homoeopathic Medical College |
Room no 5, 3rd floor, Department of Materia Medica (Phd), Rajkot homoeopathic medical College, makkam chowk, bhakti Nagar,rajkot, Gujarat,India Pincode-360002
Rajkot
GUJARAT |
09737152471
niteshbabariya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research- Rajkot Homoeopathic Medical College, Parul University, Gujarat |
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 |
Acid Phosphoricum 30C Potency / Acid Phosphoricum Mother Tincture |
The study evaluates the effect of Acid Phosphoricum 30C potency and Acid Phosphoricum Mother Tincture, both homeopathic treatments, on blood glucose regulation, clinical features of Type 2 Diabetes Mellitus, and HbA1c levels. These treatments are administered according to homeopathic principles, aiming to treat the individual holistically, focusing on improving general well-being and reducing symptoms of diabetes. |
| Comparator Agent |
Conventional Diabetes Medications (e.g., Metformin, Sulfonylureas, Insulin Therapy) |
The comparator includes commonly prescribed oral hypoglycemic agents (such as Metformin, Sulfonylureas) and insulin therapy, used in the management of Type 2 Diabetes Mellitus. These treatments aim to control blood glucose levels and improve glycemic control through pharmacological means. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Samples aged from 30 to 80 years are included.
Subjects of both sexes, irrespective of socio-economic status are included.
Diagnostic criteria are based mainly on clinical presentation and blood & urine investigation are included.
|
|
| ExclusionCriteria |
| Details |
Patients Below 30 And Above 80 Years Of Age With Type 2 Diabetes Mellitus Are Excluded.
Diabetes Mellitus With Complications Like Gangrene, Amputation And Retinal Damage Etc Are Excluded.
Diabetes Associated With Other Systemic Diseases Which Are On Active Treatment Are Excluded.
Those Not Willing To Participate In The Study.
Pregnant And Lactating Mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disappearance Of The Clinical Features Of Type 2 Diabetes Mellitus, But Recurrence Of The Same With Less Intensity, With General Well-Being Of Patient, |
Baseline (Week 0): Record initial clinical features and HbA1c levels.
Week 4: Assess early symptom changes and well-being.
Week 8: Evaluate symptom progression and recurrence.
Week 12: Review treatment response and general health.
Week 24: Assess long-term improvement and relapse.
Follow-up intervals may be adjusted based on patient response.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycemic Variability Monitoring fluctuations in blood glucose levels over time. |
Baseline (Week 0) Record pre-treatment fasting & postprandial glucose levels.
Week 2 Assess early fluctuations & response.
Week 4 Evaluate short-term variability.
Week 8 Monitor trends & stabilization.
Week 12 Review mid-term metabolic response.
Week 24 Assess long-term effects.
Additional assessments may be done as needed.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/03/2025 |
| 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
|
Diabetes mellitus (DM) is a growing global health concern and a leading cause of mortality, particularly in developed nations. India has seen a significant rise in diabetes cases, with current estimates exceeding 77 million patients. Projections indicate that by 2025, India will have the highest number of diabetics worldwide. Uncontrolled diabetes leads to severe complications, including blindness, amputations, and kidney failure. Conventional treatments, including insulin and oral hypoglycemic agents, have effectively managed diabetes but often come with adverse effects such as hypoglycemia, liver toxicity, gastrointestinal issues, and metabolic imbalances. Given the increasing prevalence of diabetes, alternative approaches like homeopathy are being explored. Homeopathy, based on principles of individualization and holistic healing, aims to treat the patient rather than just the disease. This study evaluates the effectiveness of Acid Phosphoricum 30C potency versus Acid Phosphoricum mother tincture in managing Type 2 Diabetes Mellitus. By assessing their impact on blood sugar regulation and overall patient well-being, this research aims to explore homeopathy as a complementary or alternative therapeutic option for diabetes management. |