A Randomized placebo controlled clinical study to evaluate the efficacy of a plant based Nutraceutical formulation in patients with hypothyroidism

Primary hypothyroidism is a chronic endocrine disorder in which many patients continue to experience symptoms such as fatigue, lethargy, sleep disturbances, cognitive complaints, and reduced functional capacity despite receiving standard thyroxine therapy. These persistent symptoms may significantly affect quality of life and daily functioning, indicating a need for safe adjunctive interventions that can support overall clinical outcomes.

Plant-derived bioactive compounds have been investigated for their potential role in supporting thyroid physiology and systemic metabolic balance; however, controlled clinical evidence evaluating such formulations as adjuncts to standard therapy remains limited. Evaluating both efficacy and safety in a randomized, placebo-controlled setting was therefore considered necessary.

This randomized, single-blind, placebo-controlled, parallel-group clinical study evaluated the efficacy and safety of ThyPhy for Balance as an adjunct to levothyroxine therapy in adults with primary hypothyroidism over 12 weeks. A total of 150 participants were randomized (75 per group), and all completed the study.

Primary outcome:

Both groups demonstrated increases in Free T3 and Free T4 (p<0.001). Intergroup comparison at Week 12 showed significantly higher Free T4 (p=0.038) and significantly lower TSH (p=0.024) in the intervention group compared with placebo, while Free T3 did not differ significantly between groups (p=0.071). TSH reduction reached statistical significance only in the intervention group (p<0.001).

Secondary Outcome:

Intervention group showed statiscally significant improvement (p<0.001) in reduction of secondary outcomes including fatigue, lethargy, irritability, insomnia, dysphagia, forgetfulness, constipation.

Other symptoms such as swelling, weight gain, menstrual irregularity, and breathlessness improved in both groups.

Hashimoto’s subgroup: In participants with elevated TPO antibodies, mean TSH increased over 12 weeks in both groups, consistent with the known variability of autoimmune hypothyroidism. Despite this biochemical variability, symptom improvement was observed in the intervention group.

Safety: No adverse events, serious adverse events, or treatment discontinuations were reported.

Conclusion: Adjunct administration of ThyPhy for Balance was associated with greater percentage improvement in several clinical symptoms and favorable changes in thyroid function parameters compared with placebo over 12 weeks, with good tolerability and safety.