| CTRI Number |
CTRI/2025/03/081750 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Homoeopathic Treatment In Cases Of Hypothyroidism |
|
Scientific Title of Study
|
A Clinical Study On Individualized Homoeopathic Medicines In The Managment Of Hypothyroidism Based On Kent Evaluation Of Symptoms |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishali |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical Colleg e and hospital viraj khand 1 Gomti Nagar LucknowUttar Pradesh |
| Address |
State National Homoeopathic Medical college and hospital
Virat khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9910035947 |
| Fax |
|
| Email |
vaishali0898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Iffat Ahmad Rayeen |
| Designation |
Assistant professor |
| Affiliation |
State National Homoeopathic Medical college and hospital Viral khand 1 Gomti Nagar Lucknow |
| Address |
State National Homoeopathic Medical college and hospital
Viral khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8604062779 |
| Fax |
|
| Email |
iffat.vroom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Iffat Ahmad Rayeen |
| Designation |
Assistant professor |
| Affiliation |
State National Homoeopathic Medical college and hospital Viral khand 1 Gomti Nagar Lucknow |
| Address |
State National Homoeopathic Medical college and hospital
Viral khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8604062779 |
| Fax |
|
| Email |
iffat.vroom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaishali |
| Address |
State National Homoeopathic Medical college and hospital
Viral khand 1 Gomti Nagar Lucknow 226010 Uttar Pradesh India |
| 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 Vaishali |
State National Homoeopathic Medical College and Hospital,1 Viraj Khand, Gomti Nagar , Lucknow |
Department of Organon of Medicine and Homoeopathic Philosophy , OPD-5,Gomti Nagar, Lucknow-226010
Lucknow
UTTAR PRADESH |
9910035947
vaishali0898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethical committee state national homoeopathic medical college and hospital |
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 |
Individualized homoeopathic medicine |
Intervention- The individualized homoeopathic medicine will be selected according to Dr. Kent evaluation of symptoms. Dosage- medicine will be given in varying Potencies of decimal/centesimal/50 mellesimal scale as identified from detailed case taking. Each dose shall consist of cane sugar medicated with single medicine.
Route- medicine will be Administered via oral route. Dosage-and repetition will depend upon the individual requirement of the cases as per guidelines from organon of medicine. The patient will be called for follow up after every 15 days and final assessment will be done after 6 month. At every follow up after re examination the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or Nil. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are newly diagnosed with clinical or sub clinical hypothyroidism
Patients able to give consent |
|
| ExclusionCriteria |
| Details |
Patients suffering from hypothyroidism due to pituitary insufficiency
Patients suffering from hypothyroidism along with complicated diabetes and hypertension cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether there is a significance of individualized homoeopathic medicine in management of hypothyroidism based on Kent evaluation of symptoms |
12 week to 24 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the level of TSH
TO Asses the improvement in quality of life using SF36 |
12 week to 24 week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2025 |
| 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 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 is a single arm prospective interventional study which aim to asses the utility of individualized homoeopathic medicine in the management of hypothyroidism based on Kent evaluation of symptoms. Hypothyroidism is a common endocrine disorder characterized by underproduction of thyroid hormones, leading to decreased metabolic rate and various clinical symptoms. Homoeopathy treats each patient as an individual entity, focusing on symptom similarity and individualization. Dr. J.T. Kent’s symptom evaluation technique categorizes symptoms into generals, particulars, and commons, with generals being most important. This study aims to demonstrate the effectiveness of individualized homeopathic medicine in managing hypothyroidism based on Kent’s evaluation of symptoms, with a focus on mental and physical generals. The study will evaluate patients for six months, assessing serum TSH levels and SF-36 scores pre- and post-treatment. |