| CTRI Number |
CTRI/2025/08/092702 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Zeroharm Narie Thyroid Care Tablets A Gentle, Natural Aid for Thyroid Wellness |
|
Scientific Title of Study
|
Clinical Study to Evaluate the Efficacy of Narie Thyroid Care in 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 Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Jalukbari Guwahati 14 Assam |
| Address |
Department of Prasuti Tantra Stree Roga Obstetrics Gynaecology
Kamrup
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Jalukbari Guwahati 14 Assam |
| Address |
Department of Prasuti Tantra Stree Roga Obstetrics Gynaecology
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Jalukbari Guwahati 14 Assam |
| Address |
Department of Prasuti Tantra Stree Roga Obstetrics Gynaecology
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zeroharm Sciences Private Limited Unit No. B 23 Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad Telangana Pin 500037 India |
|
|
Primary Sponsor
|
| Name |
Zeroharm Sciences Private Limited |
| Address |
Unit No. B 23, Phase 2 Technocrat Cooperative Industrial Estate Balanagar Hyderabad Telangana Pin 500037 India |
| Type of Sponsor |
Other [Neutracutical Company ] |
|
|
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 Dipak Kumar Goswami |
Government Ayurvedic College and Hospital |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology), Jalukbari Guwahti Assam Pin 781014 India
Kamrup
ASSAM |
9435400876
dr.dkgoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: Anukt, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Narie Thyroid care, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 550(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of hypothyroidism based on serum TSH,T3 and T4 levels
Subjects not suffering from any significant illness (medical / surgical)
Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mother.
suffering with Chronic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
nvestigation 1. Blood Routine Examination (Blood R/E)
2. Thyroid Profile:
Thyroid-Stimulating Hormone (TSH)
Total T4 (Thyroxine)
Total T3 (Triiodothyronine)
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waynes Index-Showing the scoring of signs and symptoms for the diagnosis of hypothyroidism |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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)
Modification(s)
|
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 clinical study evaluates the efficacy and safety of Zeroharm Narie Thyroid Care, an Ayurvedic formulation, in patients with hypothyroidism. Participants diagnosed with hypothyroidism will receive Narie Thyroid Care tablets daily for 3 months. Two follow-up visits will be conducted at 1-month intervals to assess progress and monitor safety. Laboratory tests, including TSH, T3, and T4, will be performed before and after treatment. Clinical symptoms such as fatigue, weight gain, cold intolerance, and mood changes will be tracked. Patients will be monitored for any adverse events or side effects throughout the study. The primary endpoint is improvement in thyroid hormone levels and symptom relief. Secondary endpoints include safety, compliance, and quality-of-life measures. Data will be statistically analyzed to evaluate the therapeutic effectiveness. The study aims to validate Narie Thyroid Care as a natural support for hypothyroidism management.
|