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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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