| CTRI Number |
CTRI/2024/04/066453 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Jaborandi, a Homoeopathic medicine in the treatment of Hypothyroidism |
|
Scientific Title of Study
|
Role of Jaborandi in the treatment of Hypothyroidism: Pre and Post interventional 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 |
Sophia Behera |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9853745892 |
| Fax |
|
| Email |
sophiabehera149@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD number 18, GE block,
Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD number 18, GE block,
Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106 |
| 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 Sophia Behera |
National Institute of Homoeopathy |
National Institute of Homoeopathy, Department of Homoeopathic Materia Medica, OPD number 18, Block GE, Sector 3, Salt Lake, Kolkata, West Bengal, Pin 700106
North Twentyfour Parganas
WEST BENGAL |
9853745892
sophiabehera149@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
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 |
Jaborandi 200C |
Patients will be prescribed Jaborandi if at least 50% symptoms will be matched
Jaborandi will be prescribed in 200C potency in accordance with the direction given by
Dr S Hahnemann in Organon of Medicine
Serum thyroid profile test and Zulewski’s clinical score will be measured at every 3 months of treatment for study period of 6 months. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes
Aged 20-70 years
Patient of all socio-economic classes
Patient with Serum TSH level ≥6 mIU/L
Patients having at least 50% symptoms of Jaborandi as given in Appendix 8
Patients agree to undergo some investigation, if required
Patients willing to give written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
TSH level less than 6 mIU/L
Pregnant or lactating women
Patient taking any other treatment for Hypothyroidism from other system of medicine
Patient has habit of substance abuse and/or dependence
Patient having any Psychiatric or life-threatening illness or Immuno-compromised state
Patients not willing to undergo any investigation, if so advised |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Laboratory thyroid profile findings and Zulewskis clinical score will be reviewed at every 3 months of treatment for 6 months of study period
Zulewskis Clinical Score (ZCS) for hypothyroidism This simple scoring system is based on 7 subjective symptoms and 5 physical signs of hypothyroidism Each symptom or sign if present gets 1 point and if absent gets 0 point It’s a 0 to 12 scoring scale, if total scoring more than 5 it defines hypothyroidism and if scores in between 0 and 2, it defines euthyroid status This scale was originally written in English |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Following preliminary screening for hypothyroidism symptoms and detailed screening using specified selection criteria, eligible patients will be recruited in the trial Following that, outcome data will be obtained A detailed and thorough case taking of each and every eligible patient will be done according to the format prevalent in National Institute of Homoeopathy, Kolkata, as per strict homoeopathic principles Clinical examination or relevant investigations will be done as per need Inclusion and exclusion criteria, as mentioned above, will be followed Each case will be studied properly through analysis and evaluation of symptoms and the symptoms will be matched against the symptoms of Jaborandi and if at least 50 percent symptoms which has given below, would be present then it will be included in the study SYMPTOMS OF JABORANDI 1 Mentally dullness 2 Headache from using eyes 3 Everything at a distant appear hazy 4 Hair loss 5 Dryness of skin 6 Flushing of face 7 Profuse salivation 8 Profuse perspiration 9 Deafness 10 Intense thirst 11 Profound sleep 12 Constipation 13 Worse from cold Every patient will be assessed periodically to follow up the reaction of the remedy through Serum Thyroid profile test and Zulewskis clinical score every 3 monthly The usual follow up will be done at an interval of 4 weeks and will be recorded in follow-up sheets |