| CTRI Number |
CTRI/2022/01/039213 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Homoeopathic medicine in hypothyroidism case in the age group of 14 to 60 years in both male and female |
|
Scientific Title of Study
|
The role of Homoeopathic constitutional medicine in the known case of hypothyroidism in the age group of 14 to 60 years of both the sex |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Phamdom Deepjen Singh |
| Designation |
Doctor PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College and Research Center |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College, Pune-Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7975568598 |
| Fax |
|
| Email |
deepjenphamdom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Suresh Manhas |
| Designation |
HOD Homoeopathic Philosophy and Organon of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College and Research Center |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College, Pune-Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822322533 |
| Fax |
|
| Email |
drssmanhas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Phamdom Deepjen Singh |
| Designation |
Doctor PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College and Research Center |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College, Pune-Satara Road, Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7975568598 |
| Fax |
|
| Email |
deepjenphamdom@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College and Research Center |
|
|
Primary Sponsor
|
| Name |
Phamdom Deepjen Singh |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College, Pune-Satara Road, Pune - 411043 |
| 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 |
| Phamdom Deepjen Singh |
BVDU Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research centre |
Dept. of Homoeopathic Philosophy and Organon of Medicine,Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College, Pune-Satara Road, Pune - 411043
Pune
MAHARASHTRA |
7975568598
deepjenphamdom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDUHMC Institutional Ethical Committee |
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 |
Constitutional Homoeopathic medicine |
Constitutional Homoeopathic medicine obtained after case taking will be prescribed to patients.
Potency:30C ,200C ,1M ,10M
Form: Globules or pills ,powder form .
Route of administration : ​oral route.
Duration of therapy : 6 months
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient with known case of hypothyroidism.
2.TSH value more than 5.0mlu/L
3.primary hypothyroidism |
|
| ExclusionCriteria |
| Details |
1.Patients who require medical emergency.
2.pregnant and lactating mother.
3.Advanced thyroid diseases and heart diseases.
4.Autoimmune hypothyroidism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the role of constitutional medicine in the known case of hypothyroidism in the age group of 14-60yrs of both the sex |
To assess the effectiveness of Homoeopathic medicine in hypothyroidism, follow up will be taken at every month(30 days) and thyroid function test will be done at the beginning of study(i.e day 1) and will be repeated for every 2 months(i.e 8 weeks)till the end of study(i.e 6 months). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study and compare different types of constitution and Homoeopathic medicine as preventive and curative in known case of hypothyroidism |
Follow ups taken for every 30days upto 6 months will be used to study different types of constitution and effectiveness of Homoeopathic medicines as preventive and curative in known case of hypothyroidism. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypothyroidism is treated by synthetic thyroid hormone,which long time use may lead to many side effects.Homoeopathic system of medicine is the practice of medicine that embrace a holistic natural approach to the treatment of the sick.So carefully selected Homoeopathic medicine will be given by considering the physical and mental make up of the patient.The study includes both male and female of age group between 14 to 60 years.After giving the selected medicine the thyroid function test(TSH) will be compared before and after treament and follow up will taken after every one month.The study mainly focus on the primary type of Hypothyroidism. |