A Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with Levothyroxine in the management of Primary Hypothyroidism

An Open Randamised Controlled Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with levothyroxine in the management of Primary Hypothyroidism - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078336

Enrollment

Registered

2024-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: E038- Other specified hypothyroidism

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Signs and symptoms of primary hypothyroidism- gauravata, nidradhikya, agnimandya, Shram, khalitya. 2) Subjects who are willing to give written informed consent. 3) Serum T3 and T4 within normal range and Serum TSH level above 5.5µU/ml but below 20 µU/ml.

Exclusion criteria

Exclusion criteria: 1)Secondary hypothyroidism, itrogenic hypothyroidism, post thyroidectomy. 2)Pregnant & lactating mothers 3)Uncontrolled Hypertension, Diabetes Mellitus, IHD, CVA. 4)Malignancy of Thyroid Gland 5)Any other metabolic or systemic disease conditions where other treatment is urgent and was disturb the regimen. (HIV, Diabetes Cardiovascular disease, Tuberculosis etc.) 6)Patient having myxoedema coma. 7)Patients having Down’s syndrome, Turner’s syndrome, Klinefelter’sSyndrome will be excluded. 8)Present history of any mental disorder. 9)Patient with acute and chronic gastritis, PR bleeding.

Design outcomes

Primary

Measure	Time frame
1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with levothyroxine on Kshudhamandya (poor appetite), Malavstambha(constipation), Shram(lethargy), gauravta (heavyness of the body), Khalitya (hairloss), Nidradhikya (increased sleep), etc. symptoms of primary hypothyroidism. 2.To study the effect of Varunadi Gutika as an adjuvant therapy with levothyroxine on serum TSH T3, T4 levelTimepoint: For 3 months	—

Measure

Time frame

1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with levothyroxine on Kshudhamandya (poor appetite), Malavstambha(constipation), Shram(lethargy), gauravta (heavyness of the body), Khalitya (hairloss), Nidradhikya (increased sleep), etc. symptoms of primary hypothyroidism. 2.To study the effect of Varunadi Gutika as an adjuvant therapy with levothyroxine on serum TSH T3, T4 levelTimepoint: For 3 months

—

Secondary

Measure	Time frame
1)To review the Ayurvedic & Modern literature on Primary Hypothyroidism. 2)To correlate Rasdhatvagnimandya,Rasapradoshjanya vyadhi & Primary Hypothyroidism. 3)To assess the possible mode of action of Varunadi GutikaTimepoint: At 4th 8th & 12th week	—

Countries

India

Contacts

Public ContactDr sunil Anandrao Bhaskare

R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

bhaskaresunil14@gmail.com9819165638

Outcome results