| CTRI Number |
CTRI/2025/02/080910 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research on Efficacy Of Homoeopathic Treatment in Hypothyroidism Management |
|
Scientific Title of Study
|
A Clinical study on the utility of Homoeopathic medical Repertory by Dr Robin Murphy in treatment of cases of Hypothyroidism -A prospective observation 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 Sibani Padhy |
| Designation |
PG Scholar Department of Repertory and Case Taking |
| Affiliation |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room number 07 Academic Block RBTS Govt Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
8249209171 |
| Fax |
|
| Email |
anuuusibaniii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sibani Padhy |
| Designation |
PG Scholar Department of Repertory and Case taking |
| Affiliation |
Dept of Repertory and case taking ,RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room Number 7 ,Academic Block RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, Muzaffarpur, Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
08249209171 |
| Fax |
|
| Email |
anuuusibaniii@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit |
| Designation |
Associate Professor Department of Repertory and Case taking |
| Affiliation |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Room number 07 Academic Block RBTS Govt Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical College and Hospital RDS Chowk Ramdayalu Nagar Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
Ramdayalu Nagar, Muzaffarpur, Bihar,842002 |
| 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 Sibani Padhy |
RBTS Govt Homoeopathic Medical College and Hospital |
OPD1 Medicine OPD3 Obstetrics and Gynecology OPD4 Surgery OPD7 Repertory RBTS Govt Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur Bihar India 842002
Muzaffarpur
BIHAR |
8249209171
anuuusibaniii@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeRBTS Govt Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Constitutional medicine |
Selected medicine will be given on the basis of totality of symptoms and the doses will be given according to Homoeopathic Posology and follow up should be done at 15 days interval for minimum 3 months |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 20-60 years of both sexes. Patients who give their written consent for participation.
Patients of all socio-economic classes.
Patient with Serum TSH level 26 mIU/L.
Patients agree to undergo some investigation if required. |
|
| ExclusionCriteria |
| Details |
Patients of age group below 20 years and above 60 years.
TSH level below 6 mIU/L.
Pregnant and lactating women.
Patient has habit of substance abuse and/or dependence.
Patients having any other co-morbidities like Diabetes, Hypertension, Cardiac diseases or Cancer.
Patients who have not given their consent for participation.Patient has habit of substance abuse and/or dependence.
Patients having any other co-morbidities like Diabetes, Hypertension, Cardiac diseases or Cancer.
Patients who have not given their consent for participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study we expect positive response of chosen Homoeopathic medicine upon Hypothyroidism and the Homoeopathic medical repertory by Robin murphy which is concerned for giving medicine is useful for treating Hypothyroidism |
12 weeks to 15 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will encourage patients to take homeopathic Medicine for their endocrinological problems. |
12 weeks to 15 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2025 |
| 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 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
|
Thyroid disorders especially hypothyroidism is one of the most common endocrinopathy worldwide, and its incidence is increasing rapidly. Hypothyroidism is a condition in which the thyroid gland is unable to make adequate amounts of thyroid hormone to meet the requirements of peripheral tissues. Primary hypothyroidism is characterized by failure of the thyroid gland itself; a fall in serum concentration of thyroid hormones causes an increased secretion and elevation of TSH concentration. The signs and symptoms of Hypothyroidism at the initial stage are vague and ambiguous which is often missed in its early stages and instead treated for infertility, hyperlipidemia, depression, etc. In the primary stage, the signs and symptoms are in general like fatigue, weight gain, increased blood cholesterol level, increased sensitivity to cold, constipation, dry skin, puffy face, hoarseness, muscle weakness, tenderness, and stiffness, joint pain, swelling, irregular menstrual periods or amenorrhea, dry hair or hair loss but later on affect the different systems of the body and worsen the condition of the patient. Hence, Hypothyroidism is an important public health issue. The homeopathy system of therapeutics has a great role in the treatment of Hypothyroidism. Homeopathy is a unique system of medicine based on individualization and symptom similarity of the patient. In R.B.T.S Govt. Homoeopathic Medical College & Hospital ÓPD, there are numerous patients visiting regularly seeking treatment of Hypothyroidism. The most characteristic symptom is a holistic guide to finding the patient’s specific homeopathic treatment done under principle of individualization. So, this institution is the best platform to perform such kind of study and research. I hope my Research topic will add more input on this disease and will prove helpful to patient seeking treatment of Hypothyroidism. |