| CTRI Number |
CTRI/2024/03/063404 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A RANDOMISED ALLOCATED CLINICAL STUDY TO EVALUATE THE ANTI DIABETIC EFFECT OF SULPHUR, PHOSPHORUS AND THUJA OCCIDENTALIS
|
|
Scientific Title of Study
|
A Randomised Clinical study to evaluate the Effectiveness
Of Homoeopathy Medicines
Sulphur, Phosphorus And Thuja
Occidentalis In The Management Of 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 |
DrKatari Lavanya Sai |
| Designation |
PhD scholar |
| Affiliation |
Vinayaka research foundation homoeopathy medical College Salem tamilnadu |
| Address |
Department of Pediatrics ,OPD Room No: 5d1,Vinayaka homoeopathy medical College , Salem , Tamilnadu
Department of Paediatrics, OPD Room No: 5d1,Vinayaka homoeopathy medical College , Salem , Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
07795466819 |
| Fax |
|
| Email |
dr.lavanyasai1005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr .E. Rathnasabapathi |
| Designation |
Professor Hod of Dept of paediatrics |
| Affiliation |
Vinayaka research foundation homoeopathy medical College Salem tamilnadu |
| Address |
HOD OF Department of Paediatrics, Vinayaka homoeopathy medical College , Salem , Tamilnadu
HOD OF Department of Paediatrics, Vinayaka homoeopathy medical College , Salem , Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
07795466819 |
| Fax |
|
| Email |
dr.ersabapathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKatari Lavanya Sai |
| Designation |
PhD scholar |
| Affiliation |
Vinayaka research foundation homoeopathy medical College Salem tamilnadu |
| Address |
Department of Paediatrics, OPD Room No: 5d1,Vinayaka homoeopathy medical College , Salem , Tamilnadu
Department of Paediatrics OPD Room No: 5d1,Vinayaka homoeopathy medical College Salem , Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
07795466819 |
| Fax |
|
| Email |
dr.lavanyasai1005@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinayaka mission research foundation homoeopathy medical college, salem, tamilnadu-636308 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
vinayaka mission research foundation homoeopathy medical college, salem, tamilnadu-636308 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Drkatari lavanya sai |
Vinayaka mission homoeopathy medical College & hospital, Salem , tamilnadu |
Department of Paediatrics OPD NO 5d1,Vinayaka research foundation homoeopathy medical College & hospital
Department of
Salem
TAMIL NADU |
07795466819
dr.lavanyasai1005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Mission kirupananda variyar medical college and Hospital |
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 |
Randomized allocated |
1)sulphur 30 for 6 months oral
2)Phoshorus 30 for 6 months oral
3)Thuja 30 for 6 months oral |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of ore diagnosed diabetes mellitus will be included
2.age group between 30-75years will be included
3.patients agreed for control group treatment
4patients opting for homoeopathic treatment with written consent form and regular follow up |
|
| ExclusionCriteria |
| Details |
1.pregnant and lactating women
2.pateints with severe comorbidities pertaining to diabetes mellitus
3.patients with more than 200 fbs, 300 ppbs, 9% Hba1c |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Random Blood Sugar levels , HbA1c, Urine test , Sr. Electrolytes , Sr. Creatinine |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diabetes mellitus self management Questionnaire,Morisky Medication Adherence scale , Diabetes Anxiety scale , Appraisal of Diabetes scale |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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)
|
Other (Terminated) |
| 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 is the alarming chronic disease characterized by sustainable increase of blood sugar levels. For regulation of such blood sugar levels homoeopathy medicines namely sulphur , phosphorous and Thuja Occidentalis drugs were selected for the analysis and observation |