Efficacy of Jadwar (Delphinium denudatum Wall. ex Hook.f. & Thomson) in subclinical hypothyroid patients: A single-blind, randomized placebo controlled trial.

BACKGROUND AND

OBJECTIVES

Subclinical hypothyroidism (SCH) is a thyroid disorder characterized by the absence of prominent symptoms of thyroid deficiency. It is more prevalent in women (11.4%) than in men (6.2%). While levothyroxine is commonly used to treat SCH, its use remains a topic of debate. Therefore, this study aimed to assess the efficacy of Jadwar in managing subclinical hypothyroidism.

METHODS AND MATERIALS: A randomized, single-blind, single-center, placebo-controlled study was conducted at the National Institute of Unani Medicine, Bengaluru, between August 2022 and January 2023. A total of 30 subjects, aged 20-60 years, with elevated serum thyroid-stimulating hormone (TSH) levels (4.5-15 mIU/L), were enrolled and randomly assigned to either the test group (n=15) or the placebo group (n=15). Participants in the test group received 500 mg of Jadwar, while those in the placebo group were administered placebo capsules (starch powder), with both groups taking 1 g twice a day (4 × 500 mg) for 56 days. Serum TSH and free thyroxine (FT4) levels, along with safety parameters (serum blood urea, serum creatinine, aspartate aminotransferase, and alanine aminotransferase), were measured at baseline and at the end of the trial . Additionally, subjective symptoms (fatigue, constipation, weight gain, cold intolerance, and dry skin) were evaluated every two weeks throughout the trial period.

RESULTS

The test group demonstrated significant improvement compared to the control group in subjective parameters, including fatigue and constipation, with p-values of <0.001 and 0.028, respectively. However, no significant change was observed in weight gain (p=0.159). Additionally, a significant reduction in TSH levels was noted in the test group (p<0.001) compared to the control group. Statistical analysis was performed using Student's t-test for hypothyroidism.

CONCLUSION

Treatment with Jadwar is effective for managing subclinical hypothyroidism (SCH) and demonstrates a good safety profile, with no adverse events reported.