| CTRI Number |
CTRI/2025/08/092702 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| 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)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
15/07/2026 |
| 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
Modification(s)
|
Brief Methodology: It is a single arm, Prospective, Interventional clinical study to evaluate the efficacy of the Zeroharm sciences Narie Thyroidcare intervention in the management of hypothyroidism.
Results: out of 50 enrolled participants, 2 were lost to follow up after baseline. TSH, T4, T3 and the Zulewski clinical score are based on 48 participants with the data at both time points. treatment produced highly significant improvement in both primary outcomes TSH levels decreased from 8.31 to 6.58 mIU/L (mean reduction 1.74, 20.9 %). Zulewski clinical score decreased from 5.13 to 1.77 (mean reduction 3.35 points, 65.4 %). Among secondary laboratory parameters, T3 increased significantly (113.27 to 119.90), and T4 increased significantly (8.27 to 9.08). Symptomatic assessment of the twelve Zulewski symptom components showed a statistically significant reduction in prevalence of every item (McNemars test, p< 0.05 for all). Reduction observed in the following symptoms (Diminished sweating, Hoarseness of voice, Parasthesia, Dry Skin, Constipation, Hearing impairment, Weight Increase, Slow Movements, Delayed Ankle Reflex, Coarse Skin, Periorbital Puffiness, Cold Skin) from the ranging 41 % to 87.5 %.
Conclusion: The Narie Thyroid care formulation from zeroharm sciences private limited produced statistically significant, clinically meaningful improvement in serum TSH and Zulewski clinical score in the cohort of hypothyroid participants, together significant improvement in T4, T3 and broad, significant reduction in classical hypothyroid signs and symptoms with no observed adverse effects. Narie Thyroid care is well - tolerated with complete absence of adverse events across all 48 participants. Narie Throid care can be recommended as a safe, effective and well - tolerated nutraceutical therapeutic option for the management of Hypothyroidism.
|