| CTRI Number |
CTRI/2025/02/080325 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathic medicine on patients of primary hypothyroidism with dyslipidemia |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidemia
while assessing the correlation between changes in serum TSH and total cholesterol levels:
An open label, prospective, 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 Jyoti Bhushan Dash |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
7504245877 |
| Fax |
|
| Email |
drjbdash98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Bhushan Dash |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
7504245877 |
| Fax |
|
| Email |
drjbdash98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Gautam Pal |
| Designation |
Professor, HOD, Department of Practice of Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106 |
|
|
Primary Sponsor
|
| Name |
Dr. Jyoti Bhushan Dash |
| Address |
National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106 |
| 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 Jyoti Bhushan Dash |
National institute of homoeopathy |
National Institute of Homoeopathy
Department of practice of medicine
Opd no-24
Block – GE, Sector - III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL |
7504245877
drjbdash98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National institute of homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, (2) ICD-10 Condition: E780||Pure hypercholesterolemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
individualised homoeopathic medicine will be given orally for 6 months and dose, repetition will be selected on the basis of improvement of patient |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with primary hypothyroidism having serum TSH level more than 5mIU per L
and total serum total cholesterol level more than 200mg per dl.
Patients aged between 12 to 65 years of all gender religions and socio economic status.
Patient who are willing to participate in the study and giving informed consent.
If patients taking any Homoeopathic or and Allopathic medicines for primary
hypothyroidism and also willing to participate in the study, they will be enrolled in the study
after washing period 2 months.
Patients who are willing to participate but illiterate then they will be enrolled after verbal
explanation and consent, verified by the physicians signature and patients thumb impression.
Patients who agree to undergo suggested and relevant investigations, if required. |
|
| ExclusionCriteria |
| Details |
Patients having secondary hypothyroidism, congenital hypothyroidism and subclinical
hypothyroidism.
Patients having primary dyslipidemia and secondary dyslipidemia associated of other causes.
Pregnant and lactating women.
Patients with habit of substance abuse and or dependence.
Patients having any psychiatric or life threatening illness or immune compromised state.
Patients taking any other substitutional treatment for primary hypothyroidism.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum TSH & total cholesterol levels. |
Baseline and 6 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 2 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/02/2025 |
| 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 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
|
Null Hypothesis of the study is there is no significant role of individualized homoeopathic medicine in modifying the hypothyroid state with dyslipidaemia while assessing the correlation between changes in serum TSH and total cholesterol levels. Alternative Hypothesis of the study is there is significant role of individualized homoeopathic medicine in modifying the hypothyroid state with dyslipidaemia while assessing the correlation between changes in serum TSH and total cholesterol levels. With the aim to evaluate the effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidemia while assessing the correlation between changes in serum TSH and total cholesterol levels. With the objective to assess the effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidaemia and to identify any correlation between changes in serum TSH levels and changes in serum total cholesterol levels in the age group of 12 to 65 years irrespective of gender. A detailed case taking will be done using standard proforma of hypothyroid patients associated with dyslipidemia and serum TSH & total cholesterol levels are measured. The outcomes will be assessed initially at base line and after 6 months of treatment |