| CTRI Number |
CTRI/2025/03/081845 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Test the Effectiveness, Safety, and Tolerability of Two Homeopathic Treatments (IMP1 and IMP2) for Hypothyroidism in Adults. |
|
Scientific Title of Study
|
A multicenter, randomized, double blind, placebo-controlled, three-arm, prospective, Phase 3 study to evaluate the efficacy, safety, and tolerability of IMP1 and IMP2, potentized formulations, in the treatment of patients with Hypothyroidism. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRS/24/006 Version 1.0, Original 07 January 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sachin Pawar |
| Designation |
Director Operations |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No. 706 and 706 A, 7th Floor, Gauri Commercial Complex, Plot No. 19, Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
sachin.p@clinicaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
Medical Monitor |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No. 706 and 706 A, 7th Floor, Gauri Commercial Complex, Plot No. 19, Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
drajay.m@clinicaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Pravinkumar Pal |
| Designation |
Head Clinical Operations |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No. 706 and 706 A, 7th Floor, Gauri Commercial Complex, Plot No. 19, Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
pravinkumar.pal@clinicaresearch.com |
|
|
Source of Monetary or Material Support
|
| Biosimilia Pvt. Ltd
411, Krushal Commercial Complex, G M Road, Chembur, Mumbai 4000 89, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Biosimilia Pvt. Ltd |
| Address |
411, Krushal Commercial Complex, G M Road, Chembur, Mumbai 4000 89, Maharashtra, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Pal |
Bhavna Clinic |
J. 26 HIG world bank, Ground floor, Barra, Kanpur-208027, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH |
8957543074
dr.divya15@gmail.com |
| Dr Rajeev Bhaiya Maurya |
Janta Hospital and Maternity Centre |
OPD No. 1, Ground Floor, Near Water Head Tank, Amara, Akhari Bypass, Chunar Road, Varanasi - 221011
Varanasi
UTTAR PRADESH |
9044444809
drrbm0@gmail.com |
| Dr Kavya J |
Rajalakshmi Hospital and Research Centre |
OPD No. 1, 21/1, Lakshmi Pura Main Road, Oppo Lakshmipura lake, Vidyaranyapura Post, Bangalore - 560097
Bangalore
KARNATAKA |
9035213645
kavya10431@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee Raja Nursing Home |
Approved |
| Krishna Ethics Committee |
Approved |
| Rajalakshmi Hospital Institutional Ethics 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 |
IMP1 potentized homeopathic formulation |
6 pills sublingually twice a day for 16 weeks |
| Intervention |
IMP2 potentized homeopathic formulation |
6 pills sublingually twice a day for 16 weeks |
| Comparator Agent |
Placebo |
6 pills sublingually twice a day for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Provision of signed and dated informed consent form.
2. Participants who are diagnosed with hypothyroidism, but not on any medicinal treatment for the same.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Participants must have a BMI between 18.5 Kg per m2 to 30.0 Kg per m2 (inclusive) at Screening Visit.
5. Serum TSH at screening between 5.0 µIU per ml to10.0 µIU per ml.
6. Ability to take oral medication and be willing to adhere to the study intervention regimen.
7. For females of reproductive potential: use of highly effective contraception during study participation and for an additional 1 Month after the end of study intervention administration.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
9. Agreement to adhere to Lifestyle Considerations throughout study duration. |
|
| ExclusionCriteria |
| Details |
1. Participants suffering from congenital hypothyroidism.
2. Serum TSH at Screening less than 5.0 µIU per ml or above 10.0 µIU per ml.
3. Participants already undergoing Levothyroxine sodium therapy for hypothyroidism.
4. Known cases of secondary hypothyroidism.
5. Abnormal ECG results thought to be potentially clinically significant according to the Investigator or designee, or QT prolongation (QTcF more than equal to 450 msec for male participants or more than equal to 470 msec for female participants) at the Screening Visit.
6. Clinically significant results according to the Investigator or designee, on physical examination, medical history, ECG, hematology, clinical chemistry that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
7. Sitting systolic BP [more than equal to 140 mm Hg or less than equal to 90 mm Hg] or sitting diastolic BP [more than equal to 90 mm Hg or less than equal to 50 mm Hg] at the Screening Visit. (Untreated cases of hypertension.)
8. Pregnant (positive urine pregnancy test at screening or baseline visits) or breast feeding participants or subject planning a pregnancy in the next months.
9. Known allergic reactions or hypersensitivity to components of the study intervention.
10. Treatment with another investigational drug or other intervention within 3 months.
11. Reports smoking of more than 10 cigarettes per day, use of more than 4 packets per day of tobacco products or use of nicotine products (patches, gums, etc.) corresponding to more than 10 cigarettes per day or who are unable to abstain from smoking during the participation in the study.
12. Cancer pathology, active or in remission for less than 5 years.
13. History of alcoholism, drug abuse (within the previous 5 years) or severe psychiatric diseases that could invalidate the informed consent or limit the participant compliance with protocol requirements.
14. Co-morbidities (e.g. known cases of cardiac heart failure, active arrhythmias or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficient, seriously compromised hepatic, renal and or respiratory functions)
15. Presence of any medical condition or other circumstances which would significantly affect the safety of the participant or decrease the chance of obtaining reliable data, achieving study objectives or completing the study
16. Participants already undergoing homeopathic treatment for any chronic diseases
17. The participant has a concurrent disease, condition, or is in a situation which, in the Investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
18. Directly or indirectly involved in the conduct and administration of this study as an Investigator, sub-investigator, study coordinator, or other study staff member; or employee of the Sponsor or a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in serum level of TSH at the end of the 16 weeks treatment period with respect to its baseline. |
End of the 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in serum level of TSH at the end of the 8 weeks treatment period with respect to its baseline. |
End of the 8 weeks |
| Change in serum level of free T3 and free T4 at the end of the 8 and or 16 weeks treatment period with respect to its baseline. |
End of the 8 and or 16 weeks |
| Change in Zulewski’s clinical scoring for hypothyroidism from baseline to end of the study. |
End of the 16 weeks |
| Change in Health-related quality of life (HRQoL) Short Form Health Survey (SF36) from baseline to end of the study. |
End of the 16 weeks |
| The proportion of study participants reporting incidences of AE and/or SAE during the study and their assessment with respect to intensity, duration, pattern, and causal relationship to the study medication. |
Day 1, 8 weeks and 16 weeks |
| Changes in Laboratory Safety Parameters (Hematology, and Serum Biochemistry analysis) from baseline to end of the study. |
End of the 16 weeks |
| Changes in Vital Signs from baseline to end of the study. |
End of the 16 weeks |
| Change in body weight from baseline to end of the study. |
End of the 16 weeks |
| Global tolerability assessment by patients and investigators at the end of the treatment on a 3-point scale ranging from “good tolerability (side effects may be mild or not observed)” to “poor tolerability (side effects severe or warranting/needing discontinuation)”. |
End of the 16 weeks |
| Percent Change from Baseline Mean in Anti TPOAb Levels. |
End of the 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/03/2025 |
| Date of Study Completion (India) |
07/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a multicenter, randomized, double blind, placebo-controlled, three-arm, prospective, Phase 3 study to evaluate the efficacy, safety, and tolerability of IMP1 and IMP2, potentized formulations, in the treatment of patients with Hypothyroidism.Efficacy will be evaluated by measurement of the Change in the Serum level of TSH, Free T3, Free T4, and Anti-TPOAb levels.Adverse events (AEs) and SAEs will be collected throughout the study. The assessment of the tolerability of study drug will be based on incidence of AEs and SAEs and global tolerability assessment. The design for this study is developed based upon the findings of the preclinical study. |