| CTRI Number |
CTRI/2025/06/089707 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMOEOPATHIC MEDICINES IN TREATMENT OF AUTOIMMUNE HYPOTHYROIDISM |
|
Scientific Title of Study
|
A CLINICAL STUDY TO ASSESS THE EFFECTIVENESS AND SYMPTOMATOLOGY OF COMMONLY INDICATED HOMOEOPATHIC REMEDIES IN THE TREATMENT OF AUTOIMMUNE HYPOTHYROIDISM |
| 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 VIJAY KRISHNA V |
| Designation |
PROFESSOR AND PG GUIDE |
| Affiliation |
GHMCH BANGLORE |
| Address |
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SIDDIAH PURANIK ROAD BASAVESHWARNAGAR BANGLORE
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SIDDIAH PURANIK ROAD BASAVESHWARNAGAR BANGLORE
Bangalore
KARNATAKA
560097
India |
| Phone |
9845565476 |
| Fax |
|
| Email |
doc_vIjaykrishna@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY KRISHNA V |
| Designation |
PROFESSOR AND PG GUIDE |
| Affiliation |
GHMCH BANGLORE |
| Address |
Department of materia medica
Guide Name: Dr Munjal Thakur
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SIDDIAH PURANIK ROAD BASAVESHWARNAGAR BANGLORE
Bangalore
KARNATAKA
560097
India |
| Phone |
9845565476 |
| Fax |
|
| Email |
doc_vIjaykrishna@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Vijay krishna V |
| Designation |
Professor and PG guide |
| Affiliation |
GHMCH BANGLORE |
| Address |
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SIDDIAH PURANIK ROAD BASAVESHWARNAGAR BANGLORE
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SIDDIAH PURANIK ROAD BASAVESHWARNAGAR BANGLORE
Bangalore
KARNATAKA
560097
India |
| Phone |
9845565476 |
| Fax |
|
| Email |
doc_vIjaykrishna@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government homoeopathic medical college and Hospital basaveshwarnagar banglore Hospital for infrastructural support |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Rajeshwari Principal |
Government Homoeopathic medical college and hospital Banglore |
siddiah puranik road basaveshwarnagar banglore
Bangalore
KARNATAKA |
08023359413
ghmchprincipal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE FOR HUMAN RESEARCH A |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E063||Autoimmune thyroiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A CLINICAL STUDY TO ASSESS THE EFFECTIVENESS AND SYMPTOMATOLOGY OF COMMONLY INDICATED HOMOEOPATHIC REMEDIES IN THE TREATMENT OF AUTOIMMUNE HYPOTHYROIDISM |
HOMOEOPATHIC REMEDIES IN THE TREATMENT OF AUTOIMMUNE HYPOTHYROIDISM |
| Comparator Agent |
No Comparator |
individualized homoeopathic remedy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with autoimmune hypothyroidism who fulfill the diagnostic criteria in the age group of 18– 65 years.
Subjects who are willing to take part in the study and sign the written informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects with Grave’s disease.
Subjects with Thyroid malignancy or any other malignancy
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the effectiveness of commonly indicated Homoeopathic remedies in the treatment of Autoimmune hypothyroidism |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To understand the symptomatology of commonly indicated Homoeopathic remedies in the treatment of Autoimmune hypothyroidism |
24 months |
|
|
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)
|
10/07/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
| Hypothyroidism may be defined as a deficient thyroidal production of thyroidal hormones. It could either be due to problems in the thyroid gland itself (primary hypothyroidism) or may be caused by an insufficient stimulation of the thyroid gland due to factors interfering with pituitary TSH release (secondary hypothyroidism) or indirectly by diminishing hypothalamic TRH release (tertiary hypothyroidism). Secondary and tertiary hypothyroidism are together known as central hypothyroidism and are rare. Whereas Primary hypothyroidism is very prevalent worldwide The prevalence of hypothyroidism in India was found to be 11% with higher rates in women as compared to men Overt primary hypothyroidism is diagnosed biochemically with a serum thyroid stimulating hormone (TSH) concentration above the reference range and low free T4 If the TSH is raised but free T4 is in the normal range, then this is referred to as subclinical hypothyroidism The commonest cause of primary hypothyroidism is autoimmune thyroiditis accounting for 90 % of all cases. Hashimoto’s thyroiditis (70%) and Graves’ disease (20%) are the most common types of autoimmune thyroid diseases Hashimoto’s thyroiditis diagnosis depends on the level of circulating antibodies mainly Anti-Thyroid Peroxidase antibody which contributes for about 90% sensitivity to diagnose autoimmune thyroiditis | |