Effect of Tab Thyrosutra as an add-on treatment for management of hypothyroidism: A randomized clinical trial

Hypothyroidism is a common endocrine disorder characterized by inadequate production of thyroid hormones, leading to widespread metabolic, hematological, cardiovascular, and neuropsychological disturbances. Despite the effectiveness of conventional hormone replacement therapy, many patients continue to experience persistent symptoms such as weight gain, fatigue, constipation, mood disturbances, and poor quality of life. In this context, the present clinical study was designed to evaluate the efficacy and safety of Tablet Thyrosutra as an adjunctive therapy in the management of hypothyroidism, with comparison to placebo.

A total of 68 patients were initially enrolled in the study, of whom 60 completed the trial. The completed participants were equally distributed into two groups: the test drug group (Group A) and the placebo group (Group B), each comprising 30 patients. Group A received tablet Thyrosutra 600 mg; 2 tablets twice a day after food in addition to ongoing dose of levothyroxin. Group B received Tablet placebo 600 mg; 2 tablets in addition to ongoing dose of levothyroxin for 3 months. Follow up was taken at each month. Biochemical parameters like CBC, LFT, RFT and Thyroid profile (T3, T4 and TSH) was done before enrollment and after the trial period i.e. after 90 days. The dropout rate was within acceptable limits and did not adversely affect the validity of the study. Baseline demographic characteristics such as religion, socio-economic status, educational qualification, occupational status, marital status, Desha, treatment history, and family history were largely comparable between the two groups, ensuring homogeneity and minimizing confounding factors.

The majority of participants were middle-aged women, predominantly married and belonging to middle or lower-middle socio-economic classes, reflecting the known epidemiological pattern of hypothyroidism. All participants were receiving standard allopathic treatment for hypothyroidism, indicating that Thyrosutra was evaluated as an adjunct rather than a replacement therapy, which enhances the clinical relevance of the findings.

The study assessed multiple outcome measures, including clinical symptoms, anthropometric parameters, vital signs, hematological indices, thyroid hormonal profile, biochemical safety parameters, and Ayurvedic clinical features. Clinical assessment revealed that Thyrosutra produced marked improvement in cardinal hypothyroid symptoms such as weight gain, constipation, facial puffiness, cold intolerance, fatigue, muscle weakness, mood swings, hair fall, and dryness of skin. The magnitude of improvement in the test drug group was consistently greater than that observed in the placebo group, where symptom relief was mild and inconsistent. This strongly suggests a specific therapeutic effect of Thyrosutra beyond placebo response.

Anthropometric evaluation showed a statistically significant reduction in body weight and body mass index (BMI) in the Thyrosutra group. Weight gain is a hallmark of hypothyroidism due to reduced basal metabolic rate and impaired lipid metabolism. The observed reduction in weight and BMI indicates improved metabolic efficiency and restoration of metabolic balance. Although the placebo group also showed mild weight reduction, the changes were smaller and less consistent, highlighting the superiority of the test drug.

Vital parameters remained largely stable throughout the study in both groups, demonstrating good tolerability of the intervention. Notably, a significant reduction in systolic blood pressure was observed in the Thyrosutra group, while diastolic blood pressure, pulse rate, respiratory rate, and body temperature did not show significant changes. This suggests a favorable cardiovascular modulation without disturbing physiological homeostasis.

Hematological assessment revealed important findings. Peripheral blood smear analysis demonstrated a qualitative improvement in red blood cell (RBC) morphology in the Thyrosutra group, with a marked increase in normocytic normochromic RBCs and reduction in abnormal forms such as microcytic hypochromic cells. Hemoglobin levels also showed significant improvement, indicating enhanced erythropoiesis and hemoglobinization. These changes were not observed in the placebo group, suggesting that Thyrosutra positively influences hematological health, which is often compromised in hypothyroid patients.

One of the most significant outcomes of the study was the improvement in the thyroid hormonal profile in the Thyrosutra group. A statistically significant reduction in serum thyroid-stimulating hormone (TSH) levels accompanied by an increase in serum thyroxine (T4) levels indicates improved thyroid hormone availability and better regulation of the hypothalamic–pituitary–thyroid axis. Serum triiodothyronine (T3) levels did not show a significant change, which may be attributed to peripheral conversion mechanisms or the duration of the study. The placebo group did not demonstrate significant hormonal changes, reinforcing the disease-modifying potential of Thyrosutra.

Safety evaluation was an integral part of the study. Biochemical parameters, including liver function tests and renal function tests, remained within normal limits throughout the study period. No serious adverse events were reported, and vital parameters remained stable, confirming that Thyrosutra is safe and well tolerated when used alongside standard allopathic therapy.

From an Ayurvedic perspective, hypothyroidism can be correlated with Agni Mandya, Kapha–Vata Dushti, and impairment of Rasa, Rakta, and Meda Dhatu, along with involvement of Rasavaha and Medovaha Srotas. The observed improvements in digestion, metabolism, tissue nourishment, and systemic symptoms suggest that Thyrosutra acts by correcting these underlying pathological factors rather than providing mere symptomatic relief. The reduction in weight, improvement in bowel habits, enhancement of energy levels, and normalization of hematological parameters support this holistic mode of action.

Placebo comparison revealed that although mild improvements were observed in some parameters in the placebo group, these changes were inconsistent and lacked statistical and clinical significance. The consistent superiority of Thyrosutra across clinical, hormonal, hematological, and metabolic parameters confirms its therapeutic efficacy.

In summary, the present study demonstrates that Tablet Thyrosutra is an effective, safe, and well-tolerated adjunctive therapy in the management of hypothyroidism. It provides multidimensional benefits by improving clinical symptoms, metabolic balance, thyroid hormone regulation, hematological status, and overall quality of life. The findings support its potential role in integrative management of hypothyroidism. However, larger sample sizes, longer duration of intervention, and multicentric trials are recommended to further validate these results and to explore its long-term impact on disease progression and dependency on conventional hormone replacement therapy.

Conclusion

The present study evaluated the efficacy and safety of Tablet Thyrosutra as an adjunctive therapy in the management of hypothyroidism, in comparison with placebo. The findings indicate that Thyrosutra provides clinically meaningful benefits across multiple domains while maintaining a favorable safety profile.

Participants in both groups were comparable at baseline, ensuring validity of the results. Thyrosutra demonstrated superior improvement over placebo in major hypothyroid symptoms including weight gain, constipation, facial puffiness, cold intolerance, fatigue, muscle weakness, mood disturbances, hair fall, and dryness of skin. These improvements were consistent and exceeded the mild and inconsistent changes observed in the placebo group, suggesting a true therapeutic effect.

A significant reduction in body weight and body mass index in the Thyrosutra group reflects improved metabolic regulation. Favorable modulation of the thyroid hormonal profile, evidenced by a reduction in serum TSH levels and an increase in serum T4 levels, indicates improved thyroid function and better regulation of the hypothalamic–pituitary–thyroid axis. Improvement in hemoglobin levels and red blood cell morphology further supports enhanced metabolic and hematopoietic status.

Importantly, Thyrosutra was safe and well tolerated, with no significant adverse effects or derangements in vital parameters, hepatic, or renal functions.

In conclusion, Tablet Thyrosutra appears to be an effective and safe adjunctive therapy in hypothyroidism