Clinical study to compare the effect of Ayurvedic formulations, Agnimukha Choorna and Yavakshara-Shunthi Choorna in managing early stage hypothyroidism

Efficacy and Safety of Agnimukha Choorna and Yavakshara-Shunthi Choorna in the management of Dhatvagnimandhya w.s.r. subclinical hypothyroidism: An open-label randomized comparative parallel-group study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100696

Enrollment

Registered

2026-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals of any gender aged 18-60 years. 2. On the basis of raised serum TSH (4.5-9.9 mIU/ L) and normal serum FT3 & FT4 level. 3. On the basis of clinical features of Dhatvagnimandhya. 4. Subjects willing to provide written informed consent and able to come for follow up on scheduled visits.

Exclusion criteria

Exclusion criteria: 1. Subjects already taking levothyroxine. 2. Subjects having BMI more than or equals to 40. 3. Subjects having any other comorbidities or systemic illness such as DMT2, Uncontrolled HTN (more than or equals to 160/100mm Hg), cardiovascular disease, stroke, pulmonary disease, tuberculosis, psychiatric illness, HIV. 4. Subjects with history or active malignancy. 5. Subject suffering from any hepatic disorder (SGPT and SGOT more than three times the upper limit of normal). 6. Subjects suffering from chronic kidney disease or any renal disorder (serum creatinine more than 1.2 mg/dL). 7. Pregnant and Lactating women. 8. Subjects having hypersensitivity to any of the trial interventions or their ingredients.

Design outcomes

Primary

Measure	Time frame
1 Change in Serum TSH Level from baseline. 2 Change in Zulewski s Clinical Score for hypothyroidism. Timepoint: 1 Change in Serum TSH Level- At Screening and Day 90. 2 Change in Zulewski s Clinical Score for hypothyroidism- Baseline, Day 15, Day 30, Day 45, Day 60, Day 75 and Day 90	—

Secondary

Measure	Time frame
Change in BMI & Lipid profileTimepoint: At Screening & Day 90;Change in health related Quality of life assessed through SF12 questionnaire.Timepoint: At Baseline & Day 90;Incidence of Adverse events, if anyTimepoint: Day 15, Day 30, Day 45, Day 60, Day 75, Day 90;Change in Laboratory safety parameters LFT, KFTTimepoint: At screening & Day 90	—

Countries

India

Contacts

Public ContactDr Sujata Yadav

Ayurvedic and Unani Tibbia College and Hospital

sujatakcdelhi@gmail.com9810571653

Outcome results