| CTRI Number |
CTRI/2024/05/067187 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on effectiveness of homoeopathic medicine Thyroidinum in Hypothyroidism |
|
Scientific Title of Study
|
Effectiveness of homoeopathic potentized medicine Thyroidinum in reduction of serum TSH levels in Hypothyroidism : A Single Arm Clinical 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 Sudhanshu Mishra |
| Designation |
Post Graduate Scholar, Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
State National Homoeopathic Medical College and Hospital,
Viraj Khand 1,
Gomtinagar,
Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8887963207 |
| Fax |
|
| Email |
sudha01mishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shiv Shankar Pal |
| Designation |
Professor and HOD, Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
State National Homoeopathic Medical College and Hospital,
Viraj Khand 1,
Gomtinagar,
Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7007015607 |
| Fax |
|
| Email |
drshivshankerpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhanshu Mishra |
| Designation |
Postgraduate scholar, Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
State National Homoeopathic Medical College and Hospital,
Viraj Khand 1,
Gomtinagar,
Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8887963207 |
| Fax |
|
| Email |
sudha01mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, Viraj khand 1, Gomti nagar, Lucknow, Uttar Pradesh, India - 226010
|
|
|
Primary Sponsor
|
| Name |
Dr Sudhanshu Mishra |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy,
State National Homoeopathic Medical College and Hospital,
Viraj Khand 1,
Gomtinagar,
Lucknow. |
| 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 Sudhanshu Mishra |
State National Homoeopathic Medical College and Hospital |
Department of Organon of Medicine and Homoeopathic Philosophy,
State National Homoeopathic Medical College and Hospital,
Viraj Khand 1,
Gomtinagar,
Lucknow.
Lucknow
UTTAR PRADESH |
8887963207
sudha01mishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital |
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 |
Homoeopathic Medicine Thyroidinum |
Homoeopathic Medicine Thyroidinum will be given in the various potencies such as 3x, 6x, 3c, 6c, 30c, 200c, 1m, 10m and 50m.Potency will be chosen as per the susceptibility of patient after detailed case taking.
Doses, and duration of repetition will be according to the necessity of the case for the period of 1 year.
Route of administration will be oral. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases who are newly diagnosed with clinical or subclinical Hypothyroidism
2. Cases diagnosed with clinical and subclinical Hypothyroidism who have been taking hormone replacement therapy (levothyroxine) for a minimum period of 3 months and still the TSH level is not in the reference range
4. Cases with ability to give informed consent and comply with study. |
|
| ExclusionCriteria |
| Details |
1. Cases who are suffering from hypothyroidism and are taking levothyroxine daily and the level of TSH is in normal reference range.
2. Cases suffering from hypothyroidism due to pituitary insufficiency (secondary hypothyroidism)
3. Cases suffering from congenital Hypothyroidism
4. Hypothyroidism during pregnancy; lactating mother; in mentally retarded patients.
5. Cases who require emergency medical intervention
6. Cases suffering from Hypothyroidism along with Diabetes Mellitus, PCOD, Hypertension and severe chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The changes in the serum TSH level will be assessed. |
Every three months from baseline till the conclusion of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effective potencies of Homoeopathic Potentized Medicine Thyroidinum will be recorded. |
At the conclusion of the study. |
| The changes in quality of life using SF-36 scale will be assessed. |
At the baseline and the conclusion of the study. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
21/05/2024 |
| 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
|
This study is a single arm clinical trial to find out the effectiveness of homoeopathic potentized medicine Thyroidinum in reduction of serum TSH levels in Hypothyroidism in which the outcomes would be analysed using the serum TSH levels and SF36 questionnaire. |