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Clinical Trials/CTRI/2025/02/081276
CTRI/2025/02/081276
Not yet recruiting
Phase 2

Randomised Controlled Trial To Study The Efficacy of Vasadi Ghanvati In Primary Hypothyroidism with Reference To Kaphaj Pandu.

Shraddha Dattatray Satre1 site in 1 country80 target enrollmentStarted: March 17, 2025Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Shraddha Dattatray Satre
Enrollment
80
Locations
1
Primary Endpoint
To evaluate the efficacy of oral administration of 250 mg Vasadi. Ghan Vati twice a day with madhu for 45 days in management of primary hypothyroidism with reference to Kaphaj pandu
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is a randomised open labelled controlled clinical trial comparing the safety and efficacy of Vasari Ghan Vati 250 mg and Controlled Tablet Thyroxine 25 mcg for 45 days in 80 patients with primary hypothyroidism and effect on TSH, T3, T4 levels.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • •Cases of Hypothyroidism diagnosed according to classical features , Patients having TSH level between 4 to 20 mIU/L, Patients having T3 (0.8-2.0 ng/mL) and T4 (5.0-12.0 µg/dL), Those patients of newly diagnosed with Hypothyroidism.

Exclusion Criteria

  • •Patients having TSH level greater than 20 mIU/L, Recent thyroid surgery within 12 months, patients on prolonged medications more than 6 weeks with corticosteroid, thyroid replacement therapy, iron supplements, pregnant females and lactating mothers.

Outcomes

Primary Outcomes

To evaluate the efficacy of oral administration of 250 mg Vasadi. Ghan Vati twice a day with madhu for 45 days in management of primary hypothyroidism with reference to Kaphaj pandu

Time Frame: 15 days

Secondary Outcomes

  • To study the etiopathogenesis of Kaphaj pandu in detailed according to Ayurveda and hypothyroidism in detail according to modern aspect(To study the properties and efficacy of Vasadi Ghan Vati with madhu.)

Investigators

Sponsor
Shraddha Dattatray Satre
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Shraddha Dattatray Satre

Siddhakala ayurved mahavidyalay, sangamner

Study Sites (1)

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