| CTRI Number |
CTRI/2025/02/081167 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Diabetes |
|
Scientific Title of Study
|
Comparative study of uranium nitricum 30 versus individualized homoeopathic medicine in management of type 2DM |
| 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 Kavya Singh |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Lucknow |
| Address |
Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital,1-Viraj Khand Gomti Nagar Lucknow, Uttar Pradesh -226010
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7905334785 |
| Fax |
|
| Email |
singhkavya37@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kavya Singh |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Lucknow |
| Address |
Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital,1-Viraj Khand Gomti Nagar Lucknow, Uttar Pradesh -226010
UTTAR PRADESH 226010 India |
| Phone |
7905334785 |
| Fax |
|
| Email |
singhkavya37@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shiv Shankar Pal |
| Designation |
Retired Professor |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
E-4/1066 Mansarovar Yojana Sector O Kanpur Road Lucknow 226002 State National Homoeopathic Medical College and Hospital,1-Viraj Khand Gomti Nagar Lucknow, Uttar Pradesh -226010 Lucknow UTTAR PRADESH 226002 India |
| Phone |
7007015607 |
| Fax |
|
| Email |
drshivshankerpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital,1-Viraj Khand Gomti Nagar Lucknow,226010 Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Kavya Singh |
| Address |
Department of Organon of Medicine, State National Homoeopathic College and Hospital ,1-Viraj Khand Gomti Nagar Lucknow 226010, Uttar Pradesh |
| 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 Kavya Singh |
State National Homoeopathic Medical College and Hospital |
Department of Organon of Medicine,State National Homoeopathic Medical College and Hospital,1-Viraj Khand Gomti Nagar Lucknow, Uttar Pradesh -226010 Lucknow UTTAR PRADESH |
7905334785
singhkavya37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee State National Homeopathic Medical College and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention is planned as administrating individualized homoeopathic medicine to a group of 30 patients suffering from type 2 diabetes mellitus after detailed case taking and repertorization. Individualized homoeopathic medicine will be given in varying potencies depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine (preserved in 90% v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement in each case and the duration of intervention would be 1year and 6 months |
| Comparator Agent |
Uranium nitricum 30 |
Another group of 30 patient suffering from type 2 diabetes mellitus will be administered uranium nitricum 30. The dose and repetition will depend upon the individual requirement in each case respectively and the duration of intervention would be for period of 1 year and 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Type 2 DM (Hb A1c- 6.5% or higher) at the time of screening.
2. Patients with random blood glucose 200 mg/dl and above.
3. Patients of age group 30-70 years.
4. Patients of both sexes and all religions.
5. Patients who are previously diagnosed with Type 2 Diabetes Mellitus and are taking Oral Anti Glycemic Drugs.
6. Patient who gives their valid consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from Type 2 DM (Hb A1c --more than 10%) at the time of screening.
2. Patients with secondary complications of diabetes like nephropathy and retinopathy.
3. Patients who are taking insulin injections.
4. Patient unwilling to participate in the study.
5. Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in random blood glucose level before and after treatment in patients with type 2 diabetes mellitus at baseline and after 6 months of treatment to compare effectiveness of uranium nitricum 30 and individualized homoeopathic medicine. |
12weeks,24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare changes in DSC-R (Diabetes Symptom Checklist-Revised) at baseline and every 3 months of treatment. |
12weeks ,24 weeks |
|
|
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)
|
06/03/2025 |
| 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="6" 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
|
Diabetes is a chronic condition where the body struggles with insulin production or its effectiveness, leading to high blood glucose levels, which can damage vital systems like nerves and blood vessels. Type 2 diabetes (T2DM) is particularly prevalent, affecting millions globally, with India being the second-largest affected country. In 2019, diabetes caused 1.5 million deaths, and its prevalence is expected to rise further. While conventional treatments like oral antidiabetic drugs (OAD) and insulin offer some relief, many patients fail to achieve optimal results, prompting interest in alternative treatments, such as homeopathy. This study aims to compare the effectiveness of individualized homeopathic treatment and Uranium Nitricum 30 in managing T2DM. The primary objective is to evaluate which treatment better reduces fasting blood glucose levels and alleviates diabetes symptoms using the Diabetes Symptom Checklist. Homeopathic treatments, particularly individualized remedies, have shown promise in managing T2DM, with some studies suggesting benefits for specific remedies like Uranium Nitricum 30. The study will be conducted over a period of 18 months, involving 60 patients diagnosed with T2DM. Patients will be randomly assigned to receive either individualized homeopathic treatment or Uranium Nitricum 30. Their blood glucose levels and symptoms will be regularly monitored to assess the effectiveness of the treatments. The study will provide valuable insights into the potential of homeopathy as an alternative treatment for managing type 2 diabetes, especially in populations with limited access to conventional therapies. |