| CTRI Number |
CTRI/2025/05/086783 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Primary hypothyroidism for finding efficacy of Homoeopathic medicines |
|
Scientific Title of Study
|
Comparative study of therapeutic benefits between LM and Centesimal potencies of Constitutional Homoeopathic medicines in Primary Hypothyroidism-An Open label randomized trial |
| 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 Asla Vc |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Thottoli House
Thirurkad PO
Angadipuram
Malappuram
Kerala
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Pin 673010
Kozhikode
KERALA
679321
India |
| Phone |
9745364432 |
| Fax |
|
| Email |
aslavc44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Madhavan |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Homoeopathic Philosophy
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Pin 673010
Nil
Kozhikode
KERALA
673010
India |
| Phone |
9349731235 |
| Fax |
|
| Email |
drsmithamadhavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Madhavan |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Homoeopathic Philosophy
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Pin 673010
Nil
Kozhikode
KERALA
673010
India |
| Phone |
9349731235 |
| Fax |
|
| Email |
drsmithamadhavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Karaparamba
Kozhikode
Kerala
india
Pin 673010 |
|
|
Primary Sponsor
|
| Name |
Dr Asla V c |
| Address |
Post Graduate Scholar
Department of Homoeopathic Philosophy
Government Homoeopathic Medical College
Kozhikode
pin 673010 |
| 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 Asla Vc |
Government Homoeopathic Medical College Kozhikode |
Thyroid special op
Department of Homoeopathic Philosophy
Kozhikode
KERALA |
9745364432
aslavc44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Government Homoeopathic Medical College Kozhikode Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
constitutional homoeopathic medicine is centesimal potency |
patients are randomly allocated into 2 groups by computer generated random number table method.Constitutional medicines in centesimal potencies medicate in sugar of milk and advice to take orally for 3 months.Repetition of medicines according to the principles of homoeopathy.Maximum duration of study is of one year duration. |
| Comparator Agent |
constitutional homoeopathic medicines in LM potencies |
Constitutional medicine in LM potency administered as dry globule crushed in a few grains of sugar of milk,repeat at defenite interval for 3 months.every repitition marked by a change in degree.Maximum duration of study one year |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Cases that fulfill the diagnostic criteria
Women of age in between 15 to 60 years
TSH greater than 4.50 mIU per L with Free T4 below the reference value where reference value in between 0.8 to 1.8 ng per dl |
|
| ExclusionCriteria |
| Details |
TSH less than 0.4 mIU per L with symptoms of hyperthyroidism
TSH greater than 4.5 mIU per L Above the reference value
Patients with any other severe systemic illness
pregnant and lactating mothers
patients with severe hypothyroidism suspected myxedema cases and severe Immunodeficiency diseases like AIDS thyroid neoplasia
diagnosed cases of pituitary tumuors like TSH oma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of treatment will be assessed by TSH and Free T4 value |
The outcome of treatment at baseline after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life of patients determined by WHOQOL-Bref questionnaire score |
Base line and after 3 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aslavc44@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is an Open label randomized clinical trial involving the comparative study of therapeutic benefts between LM and Centesimal potencies of constitutional homoeopathic medicine in primary hypothyroidism. Patient who are satisfying diagnostic criteria are randomly allocated into 2 groups by computer generated random number table method.First group will be given constitutional homoeopathic medicines in centesimal potencies and for 2 nd group medicines will be given in LM potencies. Primary outcome are measured by Free T4 and TSH Values at baseline and after 3 months. Secondary outcome measured by WHOQOL-Bref Questionare score at baseline after 3 months. Final calculation of data analyzed by independent t test or Mann whitney U test. |