| CTRI Number |
CTRI/2023/08/056211 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homeopathy in Hypothyroidism |
|
Scientific Title of Study
|
Usefulness of LM homoeopathic potencies in the treatment of hypothyroidism in female patient of adult age groups i.e 19-59 A prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepti Yadav |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic medical college and Hospital |
| Address |
Department of Practice of Medicine
Room No B17
Bakson Homoeopathic medical college and Hospital
36 B Knowledge park 1
Greater Noida
Nil
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7417507423 |
| Fax |
|
| Email |
deepti9618@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika Bakshi |
| Designation |
Assisstant Professor |
| Affiliation |
Bakson Homoeopathic medical college and Hospital |
| Address |
Department of Practice of Medicine
Room No B17
Bakson Homoeopathic medical college and Hospital
36 B Knowledge park 1
Greater Noida
nil
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8377015300 |
| Fax |
|
| Email |
dranamikabakshi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika Bakshi |
| Designation |
Assisstant Professor |
| Affiliation |
Bakson Homoeopathic medical college and Hospital |
| Address |
Department of Practice of Medicine
Room No B17
Bakson Homoeopathic medical college and Hospital
36 B Knowledge park 1
Greater Noida
nil
UTTAR PRADESH
201310
India |
| Phone |
8377015300 |
| Fax |
|
| Email |
dranamikabakshi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G22
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge park 1
Greater Noida
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepti Yadav |
Bakson Homeopathic Medical College and Hospital |
Out Patient Department OPD
Room No 1
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7417507423
deepti9618@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson 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 |
Route of Administration Oral
Potency 50 Millesimal LM
Twice a day
After homeopathic case taking and repertorization of case
Follow up after 15 days |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
1 Already Diagnosed cases of hypothyroidism on the basis of clinical
investigation (TSH level >5 to 20mlu/L>
2 Patient Diagnose with primary hypothyroidism with no complication will take for this study
3 Patient not currently taking any other treatment for hypothyroidism.
4 Age group 19-59 year of female
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from other systemic illness will not taking in this study
2 Patient currently taking any other treatment for hypothyroidism.
3 Pregnant and lactating women.
4 If patient become pregnant in between study then she will be dropped out.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The changes will be assessed through TSH lab investigation reports |
Will be assessed at baseline 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
Not Applicable |
|
|
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)
|
21/08/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to manage the cases of Hypothyroidism in Female population and assess the changes in Thyroid levels (TSH) through lab investigation using individualized Homoeopathic medicine. changes will be assess at baseline 12 weeks and 24 weeks |