| CTRI Number |
CTRI/2024/07/071338 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of quality of life in prediabetes using homoeopathy medicine thyroidinum |
|
Scientific Title of Study
|
Clinical study on the prognosis of prediabetic individuals based on HbA1c levels and assessing the health related quality of life using thyroidinum |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARINI A |
| Designation |
PG SCHOLAR |
| Affiliation |
White memorial homoeo medical College and hospital |
| Address |
Department of Practice of Medicine,White memorial homoeo medical College and hospital Attoor Veeyanoor (PO)
Kanyakumari dist
TamilNadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8610716859 |
| Fax |
|
| Email |
hariniayys1067@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRichard Franklin |
| Designation |
Professor and HOD Department of Practice of Medicine |
| Affiliation |
White memorial homoeo medical College and hospital |
| Address |
Department of Practice of Medicine White memorial homoeo medical College and hospital Attoor Veeyanoor (PO)
Kanyakumari dist
TamilNadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9486452262 |
| Fax |
|
| Email |
rrfranklin24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARINI A |
| Designation |
PG SCHOLAR |
| Affiliation |
White memorial homoeo medical College and hospital |
| Address |
Department of Practice of Medicine,White memorial homoeo medical College and hospital Attoor Veeyanoor (PO)
Kanyakumari dist
TamilNadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8610716859 |
| Fax |
|
| Email |
hariniayys1067@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Practice of medicine, White memorial homoeo medical College and hospital, Attoor,kanniyakumari, Tamil Nadu, pincode -621977 |
|
|
Primary Sponsor
|
| Name |
Department of Practice of medicine, White memorial homoeo medical College and hospital |
| Address |
White memorial homoeo medical College and hospital, Attoor, Veeyanoor Po,kanniyakumari,Tamil Nadu 629177 |
| Type of Sponsor |
Private medical college |
|
|
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 Harini A |
White memorial homoeo medical College and hospital |
Department of Practice of medicine OPD unit IPD unit health camp and peripheral centers
Kanniyakumari
TAMIL NADU |
8610716859
hariniayys1067@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICAL COMMITTEE – WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy medicine , Thyroidinum |
Medicine will be administered to the patients based on the duration of illness from the date of study |
| Intervention |
Homoeopathy medicine , Thyroidinum |
Potency - based on symptom similarity .Dose- minimum dose. Route of administration - oral |
| Intervention |
Homoeopathy medicine Thyroidinum |
Assessment is based on Diabetic Risk assessment questionnaire before and after the study |
| Intervention |
Homoeopathy medicine Thyroidinum |
Medicine will be administered based on the duration of illness |
| Intervention |
Homoeopathy medicine,Thyroidinum |
Each cases will be reviewed between 1 month once interval or as their need in case of emergency and it will be followed for the period of one year |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Middle aged group of 30-55 years under sedentary lifestyle are selected
Both the sexes are included
Family history of diabetes and waist circumference of more than 90cm are included
Adults with prediabetic state will be included by assessing their HbA1C levels between 5.7-6.4 are included
Assessing the health related quality of life using Diabetes Risk Assessment Questionnaire are included |
|
| ExclusionCriteria |
| Details |
Patients with diabetes mellitus are excluded
Patients who had the history of chronic diseases
Patients who are suffering from other illness and malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Each cases is assessed using Diabetic Risk assessment questionnaire, each case will be reviewed at 1 month interval |
Each cases is assessed using Diabetic Risk assessment questionnaire, each case will be reviewed at 1 month interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study follow up and assessment of Diabetic Risk Assessment Questionnaire will be done |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
06/08/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hariniayys1067@gmail.com].
- For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Clinical study on the prognosis of prediabetic individuals based on HbA1C levels and assessing the health related quality of life using Thyroidinum Importance of the study: Homoeopathic medicine Thyroidinum is having the property to manage and reverse back from prediabetic state to normoglycemia. This will prevent the risk of Type 2 Diabetes in adults. |