A Clinical and In-Silico Study to Assess the Efficacy of Virechana Followed by Oral Medications and Analysis of Outcomes of Hamsapathyadi Kashayam on THRα And THRβ In Hypothyroidism

BACKGROUND

§  Hypothyroidism affects approximately 11% of India’s population, with coastal areas experiencing a slightly higher prevalence compared to inland cities, and females being more affected than males.

§  The condition leads to various long-term complications such as dyslipidemia, atherosclerosis, depression, and increased cardiovascular disease risk.

§  Ayurveda lacks a direct analogy for hypothyroidism, but the concept of Anukta vyadhi helps in understanding its nature, manifestations, and causative factors.

§  An in-silico study has been conducted to investigate the effects of Hamsapathyadi Kashayam on thyroid receptors (THRα & THRβ), offering deeper insights into its potential mechanisms of action.

§  This approach aims to enhance our understanding of how Hamsapathyadi Kashayam could improve thyroid function and lipid metabolism disruption at a cellular level, providing safer and more effective treatment options.

 OBJECTIVES OF THE RESEARCH PROJECT

Part1- Clinical Study

Part2- In-silico Study

The present study has been undertaken with the following objectives: -

 PRIMARY OBJECTIVES-

PART 1- To evaluate the efficacy of Virechana followed by Hamsapathyadi Kashayam and Kanchanara Guggulu in Hypothyroidism.

PART 2- To do in-silico molecular docking of active components of Hamsapathyadi Kashayam against  target receptors THRα & THRβ.

 SECONDARY OBJECTIVES-

1.     To reduce Apo-B levels in hypothyroidism and associated dyslipidemias and risk factors of atherosclerotic changes due to atypical lipid profile.

2.     To assess thyroid-specific ThyPRO-39 questionnaire in hypothyroid patients.

 INVESTIGATIONS-

Investigations

Levels of assessment

|TSH

to be assessed thrice at 0th, 49th, 98th day

|Lipid profile

to be assessed thrice at 0th, 49th, 98th day

|Apo-B

to be assessed thrice at 0th, 49th, 98th day

|CBC with ESR

to be assessed once at 0th day

|RBS

to be assessed once at 0th day

 STUDY OUTCOMES-

PRIMARY OUTCOME-

Part 1- Improvement in TSH level correction (Assumed value of TSH i.e., 7mIU/L would decline to 5.5mIU/L after the intervention)

Part 2- Positive computational outcomes of Hamsapathyadi kashayam’s stimulatory effects on THRα & THRβ.

 SECONDARY OUTCOME-

1.         Improvement in clinical features of hypothyroidism.

2.         Improvement in lipid profile in Hypothyroidism-mediated dyslipidemias through-

HDL < 40 mg/dL

TC > 200 mg/dL

TG > 140 mg/dL

TC/HDL > 05

3.         Improvement in Apo-B levels hence lowering risk factors for atherosclerotic changes and CVS accidents.

4.         Assessment of QOL of hypothyroid patients.