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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  
Name  Address 
Nil  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: Anukt,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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.

Resultsout 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.

 
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