| CTRI Number |
CTRI/2025/03/082097 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFICACY OF HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF ACQUIRED HYPOTHYROIDISM IN CHILDREN |
|
Scientific Title of Study
|
ROLE OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF PRIMARY AQUIRED HYPOTHYROIDISM IN PAEDIATRIC AGE GROUP: A SINGLE ARM PRE-POST INTERVENTIONAL STUDY |
| 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 AKSHAYA THANKACHAN |
| Designation |
PG TRAINEE |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY ,KOLKATA |
| Address |
OPD Room No 32, Department of Pediatrics, National Institute of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9061181064 |
| Fax |
|
| Email |
akshayathankachan2412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KALASAPAKAM VIJAY ANANTH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY, KOLKATA |
| Address |
OPD Room No 32, Department of Pediatrics, National Institute of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748206295 |
| Fax |
|
| Email |
vjananth74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KALASAPAKAM VIJAY ANANTH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY, KOLKATA |
| Address |
OPD Room No 32, Department of Pediatrics, National Institute of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
INDIA
WEST BENGAL
700106
India |
| Phone |
9748206295 |
| Fax |
|
| Email |
vjananth74@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF HOMOEOPATHY , GE BLOCK, SECTOR 3, SALT LAKE, KOLKATA, WEST BENGAL, 700106, INDIA |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
OPD Room No 32, Department of Pediatrics, National Institute of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
INDIA |
| Type of Sponsor |
Government 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 |
| AKSHAYA THANKACHAN |
NATIONAL INSTITUTE OF HOMOEOPATHY, KOLKATA |
OPD Room No 32, Department of Pediatrics, National Institute of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata
WEST BENGAL
700106
INDIA
Kolkata
WEST BENGAL |
09061181064
akshayathankachan2412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF HOMOEOPATHY, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Indicated individualized homoeopathic medicine will be prescribed after the proper case taking and symptom similarities. Dose and frequency of repetition will be do according to the susceptibility of the patient.
Follow up will be done monthly till 6 months from the base line. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with serum thyroid stimulating hormone (TSH) value more than 5.5 mlU/L to 100 mlU/L.
2. Patients with onset of symptoms mentioned in the Zulewski clinical score exceeding 3 months.
3. Patient with age group of 4-17 years.
4. Patients of all sexes, religions and socio-economic conditions.
5. Patients who have not taken any treatment in the last 4 weeks for hypothyroidism.
6. Patients or parents/guardians of patients who can read/ write/understand either English, Hindi or Bengali languages
7. Patient parents who are willing to give written informed consent and to participate in the study and give verbal (children aged between 7-12 years) or written assent (children aged between 12-17 years).
|
|
| ExclusionCriteria |
| Details |
1. Patients with congenital hypothyroidism, thyroid dysgenesis (aplasia, hypoplasia, ectopic gland).
2. Patients with central hypothyroidism.
3. Patients with thyroid malignancies.
4. Post ablative hypothyroidism
5. Cases with substance abuse or any psychiatric illness.
6. Congenital anomaly, critically ill and immune-compromised patients.
7. Children suffering from uncontrolled systemic diseases.
8. Simultaneous participation in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum TSH Values |
Measured at baseline and after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Zulewski’s Clinical Score (ZCS) for hypothyroidism more than 5 |
Measured at baseline and after 6 months of treatment |
| Modified Naranjo criteria for homoeopathy |
Measured at the end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2025 |
| 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) |
Open to Recruitment |
|
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
Modification(s)
|
Acquired hypothyroidism, also known as juvenile hypothyroidism, results from insufficient thyroid hormone production, leading to metabolic and neurological effects at the cellular level. It can manifest as overt hypothyroidism, where thyroid hormone levels (T4 and T3) decrease, and thyroid-stimulating hormone (TSH) levels increase.· Following preliminary screening for hypothyroidism and detailed screening using specified selection criteria, eligible patients will be recruited in the trial. Following that, outcome data will be obtained. · Specific laboratory investigations which help for the diagnosis and classification of the hypothyroidism will be advised accordingly (Serum Anti-thyroid peroxidase antibody (anti- TPO), anti-thyroglobulin antibodies (TgAb), USG Thyroid). · A detailed and thorough case taking of each and every eligible patient will be done according to the format prevalent in N.I.H, Kolkata, as per strict homoeopathic principles. · Clinical examination or relevant investigations will be done as per need. · Inclusion and exclusion criteria, as mentioned above, will be followed · Each case will be studied properly through analysis and evaluation of symptoms and the individualized homoeopathic medicine is selected according to the totality of symptoms. · Every patient will be assessed periodically to follow-up the reaction of the remedy through Serum TSH, Zulewski’s clinical score at baseline and after 6 months of treatment. MONARCH will be calculated after the study. The usual follow up will be done at an interval of 4 weeks and will be recorded in follow-up sheets. · Outcome of the treatment will be assessed by considering the symptomatic improvement of the patients and on the changes in TSH level. · Final evaluation of the data will be done by means of appropriate statistical methods.
|