| CTRI Number |
CTRI/2022/06/043495 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| 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 IN THE TREATMENT OF HYPOTHYROIDISM (THYROID DISORDER) |
|
Scientific Title of Study
|
EFFECTIVENESS OF HOMOEOPATHIC MEDICINE IN THE TREATMENT OF HYPOTHYROIDISM USING KENT’S REPERTORY: AN OPEN, OBSERVATIONAL, PROSPECTIVE CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GARIMA SINGH |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
BLOCK-GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA
WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7619046056 |
| Fax |
|
| Email |
garimas110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JITENDRA KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
BLOCK-GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA
WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9681134030 |
| Fax |
|
| Email |
drjitendrakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JITENDRA KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
BLOCK-GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA
WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9681134030 |
| Fax |
|
| Email |
drjitendrakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK-GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA
WEST BENGAL 700106 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
BLOCK-GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA
WEST BENGAL 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 GARIMA SINGH |
NATIONAL INSTITUTE OF HOMOEOPATHY |
DEPARTMENT OF CASE TAKING AND REPERTORY,OPD 10, BLOCK GE, SECTOR-III, BIDHANNAGAR, SALT LAKE,
KOLKATA-700106
North Twentyfour Parganas
WEST BENGAL |
7619046056
garimas110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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 |
INDIVIDUALISED HOMOEOPATHIC MEDICINE ON THE BASIS OF KENTS REPERTORY |
Indicated individualised homoeopathic medicine will be prescribed after the repertorisation of the case using Kent’s repertory. Dose and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending NIH outpatient or inpatient ward who is suffering from Hypothyroidism.
Patients age group 18-60 years, of any gender, of any religion, of any socio-economic background.
Patients should be knowing either Hindi, English and/or Bengali.
Patients should be given written consent.
Patients having hypothyroidism who scores above 5 in Zulewski scale.
Patients willing to do all necessary laboratory test if required.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patient who already taking homoeopathic treatment for any other chronic disease.
Patient having any serious illness and life-threatening complications.
Unwilling to take part, too sick for consultation, not giving consent to join the study.
Substance abuse and/or dependence.
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 |
| Sign and symptoms of hypothyroidism will be assessed using the score by Zulewski scale |
Baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypothyroidism is a hypometabolic state resulting from
inadequate secretion of thyroid hormone. Now a days hypothyroidism is
believed a common health issue in India, as its worldwide. Females are
more prone to get this ailment than males. Iodine deficiency remain a
common cause of hypothyroidism. In areas of iodine sufficiency, autoimmune
disease (Hashimoto’s thyroiditis) and iatrogenic causes (treatment of
hypothyroidism) are most common causes. Characteristics laboratory finding
includes a rise in TSH and fall in T3 and T4 levels. Hypothyroidism has been treated successfully with
homoeopathy. It is seen that significant decline in serum TSH values occur with
the homeopathic intervention. An open,
observational, prospective clinical study to know the effectiveness of
homoeopathic medicine in the treatment of Hypothyroidism will be taken in National
Institute of Homoeopathy, Kolkata, West Bengal. Study has a target to achieve
sample of 40 patients. Outcome assessment will be done by using Zulewski scale at
baseline and after 6 months. The score obtained by the patients will be
compared and result will be analysed as per appropriate statistical methods and
interference will be done thereafter. |