A study to compare the safety and effectiveness of a Unani medicine, Jawarish-i-Falafili, with levothyroxine in people with primary hypothyroidism

INTERVENTION: Intervention1: Jawarish‐i‐Falafali: Dose‐5g (Semisolid electuary) Twice daily Orally With water after meals for 8 Weeks Control Intervention1: Levothyroxine: Participants in the control group will receive levothyroxine orally with water at least 30 minutes before breakfast. Newly diagnosed patients: Levothyroxine 50 g once daily for 4 week, the dose will be reviewed after 4 week based on serum TSH and clinical response and adjusted according to standard clinical practice upto 100 g once daily if clinically indicated. Previously diagnosed patients already receiving levothyroxine: Their stable pre‐enrolment dose will be continued for 8 weeks, unless withdrawal or safety concerns arise. Control Intervention2: Levothyroxine: Participants in the control group will receive levothyroxine orally with water at least 30 minutes before breakfast. Newly diagnosed patients: Levothyroxine 50 g once daily for 4 week, the dose will be reviewed after 4 week based on serum TSH and clinical response and adjusted according to standard clinical practice upto 100 g once daily if clinically indicated. Previously diagnosed patients already receiving levothyroxine: Their stable pre‐enrolment dose will be continued for 8 weeks, unless withdrawal or safety concerns arise Control Intervention3: Levothyroxine: Participants in the control group will receive levothyroxine orally with water at least 30 minutes before breakfast. Newly diagnosed patients: Levothyroxine 50 g once daily for 4 week, the dose will be reviewed after 4 week based on serum TSH and clinical response and adjusted according to standard clinical practice upto 100 g once daily if clinically indicated. Previously diagnosed patients already receiving levothyroxine: Their stable pre‐enrolment dose will be continued for 8 weeks, unless withdrawal or safety concerns arise. CONDITION: Health Condition 1: E039‐ Hypothyroidism, unspecified PRIMARY OUTCOME: 1 Change in Serum Thyroid Stimulating Hormone TSH Levels from Baseline to 8 Weeks of Treatment ; 2 Change in Serum Free Thyroxine FT4 Levels from Baseline to 8 Weeks of Treatment ; ; Timepoint: At Baseline and 8 week SECONDARY OUTCOME: 1 Changes in Laboratory Parameters from Baseline to Week 8 ; 2 Change in Serum Free Triiodothyronine FT3 Levels from Baseline to Week 8 ; 3 Change in Lipid Profile Parameters from Baseline to 8 Weeks of Treatment ; 4 Change in Participants Quality of Life QoL Assessed Using the Thyroid Dependent Quality of Life Questionnaire ThyDQoL from Baseline to Week 8 ; 5 Change in Zulewski Clinical Score from Baseline to Each Clinical Assessment Visit ; Timepoint: At Baseline and week 8 Monitoring Adverse Events AEs ; Adverse effects related to either the Unani drug or control drug ; Timepoint: At 2 Weeks 4 Weeks 6 Weeks and 8 Weeks INCLUSION CRITERIA: 1 Individuals of any gender 2 Aged between 18 and 60 years 3 Participants with symptomatic subclinical primary hypothyroidism, with serum TSH between 10 and 20 mIU/L and normal serum free T4 and free T3 4 Participants with mild overt primary hypothyroidism, with serum TSH between 10 and 20 mIU/L and low serum free T4, with or without low serum free T3 5 Participants willing to provide written informed consent