| CTRI Number |
CTRI/2024/02/062939 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Thyroidinum 3X as an Interventional medicine for Paediatric Hypothyroidism |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL ANALYSIS OF THE EFFECTIVENESS OF THYROIDINUM 3X AS AN INTERVENTIONAL TREATMENT FOR PAEDIATRIC HYPOTHYROIDISM |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apparna Ilankumaran |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
Door no. 409,3rd floor,
Dept of paediatrics
Sarada Krishna homoeopathic medical college
Kulasekaram
Nil
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
08667714957 |
| Fax |
- |
| Email |
apparnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadevi A L |
| Designation |
Assistant Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
Door no. 409, 3rd floor,
Dept of paediatrics
Sarada Krishna homoeopathic medical college
Kulasekaram
Nil
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9487417921 |
| Fax |
- |
| Email |
mahaiyapp338@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apparna Ilankumaran |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
Door no 409, 3rd floor,
Dept of paediatrics
Sarada Krishna homoeopathic medical college
Kulasekaram
Nil
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
08667714957 |
| Fax |
- |
| Email |
apparnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical Hospital, OPD, IPD and Peripheral Health centres |
|
|
Primary Sponsor
|
| Name |
Apparna Ilankumaran |
| Address |
Sarada Krishna Homoeopathic Medical College and Hospital
Kulasekaram
Kanyakumari-629161 |
| 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 Apparna Ilankumaran |
Sarada Krishna Homoeopathic Medical Hospital |
Door no 409, 3rd floor
Dept of Paediatrics
Kanniyakumari
TAMIL NADU |
08667714957
apparnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna homoeopathic medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HOMOEOPATHIC CONSTITUTIONAL MEDICINE |
SINGLE MINIMUM DOSE ORALLY FOR A PERIOD OF 1 MONTH UNTIL NEXT FOLLOW UP |
| Intervention |
Thyroidinum 3X |
3 x TDS, ALONG WITH CONSTITUTIONAL MEDICINE ( SINGLE DOSE)
ORALLY
FOR A PERIOD OF 1MONTH UNTIL NEXT FOLLOW UP |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the Paediatric age group 1-18 years of age.
Patients of both sexes.
Patients diagnosed with Clinical and Subclinical Hypothyroidism
Patients with a TSH level below 20mUI/ml |
|
| ExclusionCriteria |
| Details |
Patients with congenital and autoimmune thyroid disorders
Patients with other systemic diseases |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Paediatric Hypothyroidism is one of the areas of increasing concern in the present-day
generation. With various other research being conducted in the area of hypothyroidism, the
Homoeopathic method of treatment serves to be one of the safer and gentler methods for the
restoration of health. The outcomes of this study pave way for the further research to be done
and also help us to identify the validity of the use of Thyroidinum 3 X in such cases. |
General follow up every month, with TDT review every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 4 |
|
Date of First Enrollment (India)
|
02/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/03/2024 |
| 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 Yet Recruiting |
| 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
|
Paediatric Hypothyroidism is a significant endocrine disorder characterized by an insufficient production of thyroid hormones in children. This condition is of paramount concern due to the crucial role thyroid hormones play in growth, development, and overall metabolic regulation during childhood. The prevalence of Paediatric Hypothyroidism varies globally, with congenital forms being particularly common. The aetiology can range from genetic factors to iodine deficiency, autoimmune disorders, and medication-induced hypothyroidism. Early diagnosis and intervention are crucial to mitigate these potential long-term consequences, while untreated or inadequately managed hypothyroidism can lead to a range of detrimental effects, including stunted physical growth, cognitive impairment, and delayed puberty. With advances in medical diagnostics and treatment modalities, timely identification and management of Paediatric Hypothyroidism have become more feasible, significantly improving the prognosis and quality of life for affected children. However, there remains a need for continued research to refine diagnostic approaches, treatment strategies, and long-term outcomes, ensuring that every child with hypothyroidism receives the best possible care. Exploring Homoeopathic treatment for Paediatric Hypothyroidism is warranted for several compelling reasons. While conventional medical approaches, such as levothyroxine supplementation, have demonstrated effectiveness, there is growing interest in complementary and alternative therapies. Homeopathy, a system of medicine based on individualized treatment with highly diluted substances, offers a holistic approach that may be particularly relevant in paediatric cases. This study aims to identify and explore the inclusion of Thyroidinum 3X in the therapeutic spectrum and assess its effectiveness in managing Paediatric Hypothyroidism
AIM: To evaluate the efficacy of Homeopathic medicine Thyroidinum 3X as an interventional approach in comparison to Predetermined Homoeopathic medicines for Paediatric hypothyroidism. OBJECTIVES: To evaluate the action of Thyroidinum 3X in Paediatric Hypothyroidism. To assess which predetermined Homoeopathic medicine has more effectiveness when administered along with Thyroidinum 3X for Paediatric Hypothyroidism To understand the cause of Paediatric Hypothyroidism. SCREENING: Cases diagnosed with Paediatric hypothyroidism from the OPD’s, IPD’s and Rural health centres of SKHMC will be considered for the study, based on the satisfaction of inclusion criteria. MATERIALS: Standardized case record format of SKHMC and TFT reports. SAMPLE SIZE: The 30 cases satisfying the inclusion criteria will considered for the study and then will be randomly categorized into 2 groups, with 15 each. Patients in group 1 will be administered with Constitutional medicine will the patients in group 2 will be administered with constitutional medicine along an interventional medicine Thyroidinum 3X, for a required duration. The TFT reports will be analysed every 3 months with a regular follow up for every month. ENROLLMENT: Patients within the Paediatric age group 1-18 years of age. Patients of both sexes. Patients diagnosed with Clinical and Subclinical Hypothyroidism Patients with a TSH level below 20mUI/ml. STUDY PERIOD: 1 year FOLLOW UP: Regular follow up every month, TFT every 3months |