| CTRI Number |
CTRI/2023/08/056199 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in management of Hypothyroidism |
|
Scientific Title of Study
|
Exploring the scope of Homoeopathic medicine as an adjuvant therapy or stand alone therapy in cases of hypothyroidism- A pre-test, post-test 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 Deepali Soni |
| Designation |
Asst. Professor |
| Affiliation |
S.K.R.P. Gujarati Homoeopathic Medical College Hospital and Research Center, Indore (M.P.) |
| Address |
Out Patient Department, Room No. 4, S.K.R.P. Gujarati Homoeopathic Medical College Hospital and Research Center, Indore (M.P.)
Indore
MADHYA PRADESH
452010
India |
| Phone |
8989522142 |
| Fax |
|
| Email |
drdeepalimsoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashok Yadav |
| Designation |
Head of Department |
| Affiliation |
Dr. Madan Pratap Khuteta Homoeopathic Medical College, Hospital and Research Center, Jaipur. |
| Address |
Department of Practice of Medicine, Dr. Madan Pratap Khuteta Homoeopathic Medical College, Hospital and Research Center, Jaipur.
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
drashok112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Soni |
| Designation |
Asst. Professor |
| Affiliation |
S.K.R.P. Gujarati Homoeopathic Medical College Hospital and Research Center, Indore (M.P.) |
| Address |
Out Patient Department, Room No. 4, S.K.R.P. Gujarati Homoeopathic Medical College Hospital and Research Center, Indore (M.P.)
Indore
MADHYA PRADESH
452010
India |
| Phone |
8989522142 |
| Fax |
|
| Email |
drdeepalimsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.K.R.P. Gujarati Homoeopathic Medical College, Hospital and Research Center, Indore (M.P.) |
|
|
Primary Sponsor
|
| Name |
Dr Deepali Soni |
| Address |
S.K.R.P. Gujarati Homoeopathic College, Hospital and Research Center, Scheme No. 54, Satya Sai Square, Indore (M.P.) 452010 |
| 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 Deepali Soni |
S.K.R.P. Gujarati Homoeopathic Medical College, Hospital and Research Center, Indore |
Out Patient Department, Room No. 4, S.K.R.P. Gujarati Homoeopathic Medical College, Hospital and Research Center, Scheme No. 54, A. B. Road Indore-452010
Indore
MADHYA PRADESH |
8989522142
drdeepalimsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homoeopathy University Institutional Ethical Committee, Jaipur |
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 |
Constitutional Homoeopathic Medicine will be given according to the case |
Potency- Centesimal Potency.
Dose- As per need of case.
Frequency- As per need of case.
Route of administration- Oral.
Duration- 1 year. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of 20- 60 years of age and both sexes will be considered for the study.
2. Patient presenting with the symptoms of Hypothyroidism.
3. Raised TSH levels from 5.5 µIU/ml upto 20 µIU/ml.
4. Patients giving consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient with the history of thyroidectomy.
2. Hypothyroidism in pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Thyroid Function Test |
Thyroid Function Test will be done before, during & after the study at the interval of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Zulewski’s clinical score for hypothyroidism |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/08/2023 |
| 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="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 Pre-test, Post- Test study conducted in India, to know whether the Homoeopathic medicines are effective as an adjuvant therapy or stand alone therapy in maintaining the normal TSH levels and reducing the Levothyroxine doses in cases of hypothyroidism. |