| CTRI Number |
CTRI/2023/08/056393 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines in the Treatment of Subclinical Hypothyroidism |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines in the Treatment of Subclinical Hypothyroidism: An open-label observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Niharika Shaw |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Homoeopathic Materia Medica, 1st Floor
Block-GE,Sector-III
Salt lake,KOL-700106
South Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
09038323003 |
| Fax |
|
| Email |
drniharikashaw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chintamani Nayak |
| Designation |
Associate professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Homoeopathic Materia Medica, 1st Floor
Block-GE,Sector-III
Salt lake,KOL-700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chintamani Nayak |
| Designation |
Associate professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Homoeopathic Materia Medica, 1st Floor
Block-GE,Sector-III
Salt lake,KOL-700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Dr Niharika Shaw |
| Address |
National Institute of Homoeopathy, Block-GE, Sector-III, Salt lake city, Kol-106, W.B |
| Type of Sponsor |
Other [SELF] |
|
|
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 Niharika Shaw |
NATIONAL INSTITUTE OF HOMOEOPATHY |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA
GE-BLOCK, SECTOR-III
SALT LAKE, KOLKATA-700106
Kolkata
WEST BENGAL |
09038323003
drniharikashaw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC MEDICINES |
Detailed and thorough case taking of the patient will be done in accordance with the case taking proforma.
All patients will be prescribed Individualized Homeopathic Medicine, in accordance with the direction given by Dr S. Hahnemann in ‘Organon of Medicine’.
Indicated homoeopathic remedy will be prescribed in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition.
In centesimal scale, 2 medicated globules (no. 20) in 1 grain of sugar of milk will be given. Dosage and repetition depending upon the individual requirement of the cases.
In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water in a bottle of 120 ml capacity with addition of 2 drops of 88% v/v ethanol; 16 doses to be marked on the vial; each dose Dispensary of 5 ml to be taken after 10 uniformly forceful downward strokes (from ear lobule to umbilicus which ends in a jerk) to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup.
All medicines will be dispensed from National Institute of Homoeopathy.
Serum thyroid profile test (T3, T4, TSH and fT4) will be done before and after every 3 months of treatment.
General management
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. TSH 4-10mIU/ml
2. T3- Within normal range
3. T4- Within nkrmal range
|
|
| ExclusionCriteria |
| Details |
1. TSH >10mIU/ml
2. Patient with any other major co-morbidity
3. Pregnant female
4. Patient addicted to some abuse
5. Patient taking other mode of treatment treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Following preliminary screening,outcome data will be obtained based on inclusion and exclusion criteria, as mentioned above, will be followed.
Each case will be studied properly through analysis and evaluation of each and every symptom then accordingly qualitative picture will be constructed on the basis of totality of symptom to prescribe simillimum. |
Every patient will be assessed periodically to follow-up the reaction of the remedy through ThyTSQ and Serum Thyroid profile test every 3 monthly. The usual follow up will be done at an interval of 4 weeks and will be recorded.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the standard of treatment in Subclinical hypothyroidism patients with Individualised Homoeopathic Medicines by using Thyroid Treatment Satisfaction Questionnaire (Thy-TSQ). |
6 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="0"
Months="9"
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
|
Subclinical
hypothyroidism (SCH), also known as compensated hypothyroidism or mild hypothyroidism,
a commonly found clinical entity is defined biochemically as a raised serum
concentration of thyroid stimulating hormone (TSH) with serum free thyroxine
(FT4) in normal range.
SCH commonly affects
6-17% of the Indian population. The population prevalence of SCH is
around 12-18%, diagnosis being more common in women and elderly population and
higher in whites than in black population.
Various studies and case reports have shown the efficacy of Individualised
Homoepathic Medicines in the treatment of Subclinical hypothyroidism improving
both quality of life of patient and standard of treatment of Subclinical
hypothyroidism. Homoeopathy treats the patient as a whole rather than just the
disease entity. Therefore, the aim of the study is to assess the effectiveness
of Individualised Homoepathic Medicines in the treatment of Subclinical
hypothyroidism. |