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Clinical Trials/CTRI/2025/11/096889
CTRI/2025/11/096889
Not yet recruiting
Phase 3

A RANDOMIZED CLINICO-COMPARATIVE TRAIL TO EVALUATE THE EFFICACY AND SAFETY OF GHANADI VATI AND KANCHNARA GUDIKA IN THE MANAGEMENT OF DHATVAGNIMANDYA W.S.R. TO HYPOTHYROIDISM

Dr Divya Singh Charan1 site in 1 country90 target enrollmentStarted: November 15, 2025Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Dr Divya Singh Charan
Enrollment
90
Locations
1
Primary Endpoint
The Primary outcomes are Any changes in the value of serum TSH.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

It is a randomized, prospective, open-label, interventional comparative clinical trial.

The trial consists of three groups: one will receive Ghanadi Vati, the second

group will receive Kanchnara Gudika and the third group will receive

both Ghanadi Vati,and Kanchnara Gudika together

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients having sign and symptom of Dhatwagnimandya (Hypothyroidism) will be selected for the present study.
  • •Patients having age between 18 to 60 years of either sex.Already diagnosed and Fresh patients of TSH level 5-12 mlU/L.
  • •Patients, willing to give written informed consent to participate in the study.

Exclusion Criteria

  • •Participants will be excluded if they have TSH levels more than12 mlU/L.
  • •congenital hypothyroidism and secondary hypothyroidism.
  • •any type of thyroid surgery.Patients below 18 years and above 60 years of age.
  • •uncontrolled Diabetes mellitus.
  • •poorly controlled hypertension.
  • •clinical evidence of Heart failure.Other exclusion includesAlcoholics and/or drug abusers.
  • •Pregnant/lactating woman.
  • •Any other condition which the Investigator thinks may jeopardize the study.

Outcomes

Primary Outcomes

The Primary outcomes are Any changes in the value of serum TSH.

Time Frame: Total study time 90days follow up at every 1 month

Secondary Outcomes

  • Change in T3 & T4.(Changes in status of Agni (Jatharagni Assessment).Change in RAND 36- Item Health Survey 1.0 Questionnaire.)

Investigators

Sponsor
Dr Divya Singh Charan
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Divya singh charan

Maharao Skekhaji Regional Ayurveda Research Institute Bani Park,Jhotwara road, Jaipur

Study Sites (1)

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