| CTRI Number |
CTRI/2024/06/068742 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
THIS STUDY IS CONDUCTED TO KNOW THE ROLE OF HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF SUBCLINICAL HYPOTHYROIDISM |
|
Scientific Title of Study
|
THE SCIENTIFIC TTILE OF THE STUDY IS- EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE VERSUS THYROIDINUM 3X IN THE MANAGEMENT OF SUBCLINICAL HYPOTHYROIDISM- A DOUBLE ARM 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 YASMEEN ANSARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Room no-112,Department of Practice of Medicine, Nehru Homoeopathic Medical College And Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI
110024
India |
| Phone |
7838065805 |
| Fax |
|
| Email |
dryasmeenansari5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHIT MATHUR |
| Designation |
ASSTT. PROFESSOR |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Room no-212 ,Department of Practice of Medicine, Nehru Homoeopathic Medical College And Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI
110024
India |
| Phone |
7982795765 |
| Fax |
|
| Email |
drmohitmathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YASMEEN ANSARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Room no-112,Department of Practice of Medicine, Nehru Homoeopathic Medical College And Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI
110024
India |
| Phone |
7838065805 |
| Fax |
|
| Email |
dryasmeenansari5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary or Material support will be provided by-Nehru Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
This study will primarily be sponsored by Nehru Homoeopathic Medical College And Hospital |
| Address |
Room no-112,Department of Practice of Medicine,Nehru Homoeopathic Medical College And Hospital, B-Block, Defence Colony, New Delhi-110024 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr YASMEEN ANSARI |
In patient and Out-patient department of Nehru homoeopathic medical college and hospital |
Room no-112,Department of Practice of Medicine,Nehru Homoeopathic Medical College And Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI |
07838065805
dryasmeenansari5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethical committee of Nehru Homoeopathic Medical College And Hospital, B- Block Defence Colony, New Delhi-110024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ADMINISTRATION OF THROIDINUM 3X/TWICE DAILY FOR 15 DAYS,FOR A MAXIMUM PERIOD OF 3 MONTHS. |
Upon receiving patient’s consent to participate in the research project, he/she will be
randomly allocated either to experimental or comparator arm. Each patient will receive
treatment for a period of 12 months and outcome data will be collected at monthly interval.
Data of the first three months of intervention for each patient will be analysed for research purpose. In Comparator Arm- 30 patients will be enrolled in the comparator arm through random
allocation. Thyroidinum 3x twice daily for 15 days will be given and follow up will be
taken at every 2-3 weeks, next dosage will be given according to principles of organon and
individual susceptibility.
Data for first three months of treatment for each patient will be utilised for research
outcome. |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE WILL BE GIVEN ACCORDING THE PRINCIPLES OF ORGANON OF MEDICINE FOR MAXIMUM PERIOD OF 3 MOTNHS WITH FOLLOW-UP AT EVERY 15 DAYS |
Upon receiving patient’s consent to participate in the research project, he/she will be
randomly allocated either to experimental or comparator arm. Each patient will receive
treatment for a period of 12 months and outcome data will be collected at monthly interval.
Data of the first three months of intervention for each patient will be analysed for research
purpose. In Experimental Arm-30 patients will be enrolled in the experimental arm through random
allocation. Patients will be given individualized Homoeopathic medicine after considering
totality of symptoms and follow up of each patient will be taken at every 2-3 weeks.
Potency selection will be based according to case presentation of the patient. Medicine will
be prescribed in centesimal scale in the form of globules. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between 12 to 60 years of age and willing to participate in the study.
2. Patients with elevated levels of TSH above 4.5 mIU/L and below 10.0 mIU/L and T3,
T4 within normal limits.
3. Patients with diagnosed Hashimoto’s Thyroiditis cases with TSH above average and T3,
T4 within normal limits. |
|
| ExclusionCriteria |
| Details |
1. Pregnant woman and Lactating women.
2. Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases.
3. Patients below 12 years of age. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be to reduce levels of serum TSH and bring it back within the normal range. |
Data will be collected at Baseline, after 1 month and after 3 months from the date of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary outcome will be changes in the Zulewski’s clinical score & WHO-QOL bref scale after application of individualized homoeopathic medicine & thyroidinum 3x.
|
Data will be collected at Baseline, after 1 month & after 3 months from the date of enrollment. |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="0"
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) is defined as mildly elevated thyroid-stimulating hormone
(TSH) above the normal limit (0.4-4.5 mIU/L) and below that of overt hypothyroidism (<10.0
mIU/L) despite normal serum levels of free thyroxine (T4&T3).
Aim of this study is to asses the efficacy of homoeopathic medicine in normalizing the levels of TSH in
subclinical cases of hypothyroidism Objective 1. To assess change in quality of life using WHO-QOL-Bref scale in subclinical
hypothyroidism.
2. To asses changes in the symptoms of subclinical hypothyroidism using Zulewski’s
clinical score.
3. To find out symptoms of subclinical hypothyroidism
Hypothesis and Research question Is there any significant difference in the levels of TSH before and after application of
individualized Homoeopathy (IH) and Thyroidinum 3x on subclinical hypothyroidism?
â–ª Hypothesis:
1. Null hypothesis (H0): There will be no difference between individualized
homoeopathy (IH) and Thyroidinum 3X in the management of subclinical
hypothyroidism.
2. Alternative hypothesis (HA): There will be significant difference between
individualized homoeopathy (IH) and Thyroidinum 3X in the management of
subclinical hypothyroidism.
Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College &
Hospital.
Study duration: 12 Months
Study design : A randomized, prospective, comparative study.
Selection of samples: Cases with raised TSH and normal FT3 and FT4 levels, samples
will be collected in IPD and OPD of NHMC&H
Sample Size Total 60 patients will be included in trial. 30 in Homoeopathic intervention arm
and 30 in Comparator arm.
|