| CTRI Number |
CTRI/2023/08/057128 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMEOPATHIC MEDICINE IN HYPOTHYROIDISM ASSOCIATED WITH STRESS |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic Medicine in management of patients of Hypothyroidism associated with Stress |
| 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 Soni Abhishek Madhurprakash |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO 14 Department of Organon of Medicine National Institute of Homoeopathy Block GE Sector III Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7359169008 |
| Fax |
|
| Email |
abhisheksoni062@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Afsar Ali |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine National Institute of Homoeopathy Block GE Sector III Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8101154060 |
| Fax |
|
| Email |
afsar.syed@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Afsar Ali |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Organon of Medicine National Institute of Homoeopathy Block GE Sector III Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8101154060 |
| Fax |
|
| Email |
afsar.syed@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE Sector III
Salt Lake
Kolkata 700106
|
| 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 |
| Dr Soni Abhishek Madhurprakash |
National Institute of Homoeopathy |
OPD No 14 Department of Organon of Medicine National Institute of Homoeopathy Block GE Sector III Kolkata
North Twentyfour Parganas
WEST BENGAL |
7359169008
abhisheksoni062@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of National Institute of Homoeopathy Kolkata |
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 |
| Intervention |
Individualized Homoeopathic Medicine in 50 millesimal or centesimal potency |
Medicine will be prescribed in Centesimal or Fifty Millesimal potency, according to Homoeopathic principles regarding dose, potency and repetition. Indicated Homoeopathic medicine will be administered for a period of 6 months. In 50 millesimal potency medicine will be dispensed as 1 medicated globule, size "10", mixed in 100 ml of distilled water. Rectified spirit will be added for preservation of the medicine and patient will be advised to give 10 strokes before consuming it. In Centesimal potency medicine will be dispensed in sugar of milk or "40" size globules.Total duration of therapy: 6 months for each individual patient. Data will be recorded at baseline and at 6 months for each individual patient. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from Hypothyroidism newly diagnosed with serum TSH > 10 µIU/ml confirmed with biochemical investigation and associated with stress
2.Patient age group 18-60 years, of any gender, of any religion, of any socio-economic background
3.Patents must be knowing either Hindi or English or Bengali
4.Patient should be given written consent
5.Patients willing to do all necessary laboratory test if required |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from congenital hypothyroidism, subclinical hypothyroidism
2.Patient suffering from Hypothyroidism taking Allopathic treatment for the same
3.Pregnant and lactating women
4.Patient who already taking homoeopathic treatment for any other chronic disease
5.Patient suffering from any life threatening/ Psychiatric/ illness or Immuno-compromised state or other significant disease conditions
6.Unwilling to take part, too sick for consultation, not giving consent to join the study
7.Substance abuse and/or dependence
8.Patient undergone for recent thyroid surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum TSH T3 T4 levels (Thyroid Profile) |
At baseline & after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ZULEWSKIS CLINICAL SCORE |
At baseline & after 6 months |
| PERCEIVED STRESS SCALE |
At baseline & after 6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
06/09/2023 |
| 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="1"
Months="6"
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 (ICD-10: E03.9) is a
hypometabolic state resulting from inadequate secretion of thyroid hormone for
a longer period or rarely from resistance of the peripheral tissues to the
effects of thyroid hormones. Patients who are suffering from hypothyroidism and registered in
the OPD and IPD of National Institute of Homoeopathy and fulfilling the
inclusion and exclusion criteria will be taken as sample of this study. Dose and frequency of the selected medicine will be as per the Homoeopathic
principles. Indicated Individualized homoeopathic medicine will be prescribed. Data
of Serum TSH, T3, T4 (Thyroid Profile), Zulewski’s
Clinical score and Perceived stress scale will be assessed at baseline and
after 6 months, to see the correlation ,whether with the change in Thyroid
Profile, Zulewski’s Clinical score after using individualized homeopathic
medicine ,will there also be a corresponding change in perceived stress scale. |