A RANDOMIZED, SINGLE CENTRIC, SINGLE ARM, OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THYRO-Q IN HYPOTHYROID PATIENTS ON THYROID HORMONE THERAPY
Dr. D. M. Ravi Chand* and Dr. M .V. Rama Mohan Rao
Thyroid disorders are common in the general population and contribute to significant health issues. Therefore, it is practical to diagnose and treat so as to prevent complications arising from its imbalance using one of its kind Ayurvedic modulator to combat hypothyroidism. The present study is aimed to examine the effects of fine titration of thyroxin dosage on symptoms of hypothyroidism, wellbeing and quality of life. A randomized, single centric, single arm, open label study was designed to evaluate the efficacy and safety of Thyro-Q in hypothyroid patients along with thyroid therapy. This is a randomized, single centric, single arm, open label study to evaluate the efficacy and safety of Thyro-Q in hypothyroid patients on thyroid hormone therapy. A total of 30 subjects aged 18- 60 years were enrolled in the study. All subjects underwent investigator evaluation to check if they were eligible to participate in the study. Safety assessment- Clinical examination and vital signs evaluation, Safety and tolerability was also assessed by graded scores for treatment satisfaction, Treatment preference and Quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxin-treated subjects when serum thyrotrophic (TSH) is suppressed and in the lower reference range, compared to when TSH is in the upper reference range and to identify the change in quality of life by using Health Related Quality of Life questionnaire (HRQOL- SF-36). The results shows us a change 17.06% from baseline observation to day 120 observation of TSH levels , this shows how well the drug is effective in bringing the thyroid levels to the normal range, to show the trend of how effective the drug is we have further classified baseline day to 120th day into two durations where duration 1 is baseline day to the 75th day (both drug and Thyro Q for a period of 75 days) and duration 2 is 75th day to 120 day( Thyro-Q only for 45 days ) , we see that there is a 7.5% change from baseline day to 75 day when Thyro-Q is taken along with Thyroxin and 10.33 % change from 75th to 120 day when Thyro-Q is taken alone, which indicates that if the Thyro- Q intervenes well with regular medications prescribed like thyroxine, and Thyro-Q, if used for a longer duration there will be a significant control to normalize the thyroid levels, there were no adverse drug reactions (ADS) reported in any of the study subjects during the study period. The study clearly demonstrates the benefit of Thyro-Q, a strong immune response system is induced. All the subjects who were treated with Thyro Q showed the levels of T3, T4 and TSH have drastically reduced by 24.67 %, 21.93 % and 17.06 % respectively. The results has a direct impact on the well begin of the patients in terms of life style, family pressure, beginning irrational and we observed the reduction in symptoms like dryness, blurred vision, swollen hand and neck, dry and itchy skin, felling lethargic. The subjects were able to perform their own duties and were not dependent on family or friends in taking care of tasks. They were no occurrences of adverse events like flu or gastroenteritis during the study period.
Keywords: Hypothyroid, thyroid, hormone and therapy.
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