| CTRI Number |
CTRI/2024/09/073664 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Individualized Homoeopathic Medicine in LM Potency For The Management Of Hypothyroidism |
|
Scientific Title of Study
|
The Role Of Individualized Homoeopathic Medicine In LM Potency For The Management Of Hypothyroidism |
| 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 Pooja Sojitra |
| Designation |
BHMS PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon Of Medicine
Jawaharlal Nehru Homoeopathic Medical College
Parul university
Limda
waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7096881301 |
| Fax |
|
| Email |
poojasojitra1499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna Nimavat |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon Of Medicine
Jawaharlal Nehru Homoeopathic Medical College
Parul university
Limda
waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7046705677 |
| Fax |
|
| Email |
jigna.nimavat87119@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigna Nimavat |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Organon Of Medicine
Jawaharlal Nehru Homoeopathic Medical College
Parul university
Limda
waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7046705677 |
| Fax |
|
| Email |
jigna.nimavat87119@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College,
Parul university,
Limda,
waghodia,
Vadodara 391760
Gujrat
|
|
|
Primary Sponsor
|
| Name |
Dr. Pooja Sojitra |
| Address |
Jawaharlal Nehru Homoeopathic Medical College,
Parul university,
Limda,
waghodia,
Vadodara-391760
Gujrat |
| 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 Pooja Sojitra |
Jawaharlal Nehru Homoeopathic Hospital |
Jawarlal Nehru Homoeopathic Medical college and Hospital,
Parul university,
Limda,
Waghodia- 391760
Vadodara
GUJARAT |
7096881301
poojasojitra1499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College And Hospital Institutional Ethics Committee |
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 |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine will be prescribe to individuals having Hypothyroidism.
Individualized homeopathic medicine will be prescribed exclusively in LM potency.
Dose:
1 spoonful of suitable LM potency (0/1, 0/2, 0/3,...etc.) Prescribed based on individual case requirements.
Frequency:
Daily or every other day, depending on symptom severity.
Route of Administration:
Sublingual- 1 spoonful under the tongue.
Treatment Duration:
Minimum 3 months, with regular follow-ups every 15 days
And Treatment continues until symptoms of hypothyroidism resolve. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Pre-diagnosed cases and diagnosed cases of Hypothyroidism having increase TSH
level.
2.Any sex, religion or socioeconomic status
Willing to participate in the study and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with secondary or tertiary hypothyroidism or those with hypothyroidism secondary to a surgical or radiation-induced cause.
2.Patient taking any other mode of treatment.
3.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Individualized Homoeopathic Medicines in LM Potencies are effective in Hypothyroidism.
2. Reduction of symptoms of Hypothyroidism.
3. Will measure the change in thyroid-stimulating hormone (TSH) levels.
|
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess treatment outcome in cases of Hypothyroidism using Zulewski’s clinical
score. |
3 month |
|
|
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)
|
01/10/2024 |
| 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
|
This study aims to evaluate the efficacy of individualized homoeopathic medicine in LM potency for the management of hypothyroidism. 40 patients with hypothyroidism will be recruited and treated with individualized homoeopathic medicine in LM potency for 1 year duration.The primary outcome measure will be the change in thyroid-stimulating hormone (TSH) levels as well as symptom improvement.The study will assess the effectiveness of individualized homoeopathic medicine in LM potency as a treatment option for hypothyroidism. |