Health Condition 1: E039- Hypothyroidism, unspecified
Conditions
Interventions
Intervention1: ThyPhy for Balance: Group B will consume ThyPhy for Balance alongwith Thyroxine medication empty stomach every morning
Control Intervention1: Placebo: Group A will consume Placebo along
Sponsors
Arelang Naturals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Clinically diagnosed with overt hypothyroidism within the past 6 months. On dose of thyroxine therapy for at least 1 week prior to screening. Able and willing to provide written informed consent. Willing to comply with study procedures follow up visits and sample collection. Agree to refrain from taking any new supplements or herbal products targeting thyroid during the trial. Negative pregnancy test for women of childbearing potential and commitment to use contraception during the study.
Exclusion criteria
Exclusion criteria: Pregnant or Lactating women. History of active hyperthyroidism, thyroid cancer or thyroidectomy. Presence of severe comorbidities like chronic kidney disease, liver dysfunction, cardiovascular disease. Use of other investigational drug or agent in last 30 days. Known allergy or hypersensitivity to herbal ingredients. Diagnosed with psychiatric or cognitive disorder that may affect informed consent or compliance. Individual with uncontrolled diabetes mellitus. History of substance abuse or alcohol in past 6 months. Any other concern deemed by the investigator to interfere with the participants or study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum TSH and Free T4 levels from baseline to Week 12 in intervention groupTimepoint: day zero and day ninety | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the subjective criteria which includes: Weight gain, Lethargy & Fatigue, Constipation, Puffiness of Face, Amenorrhea, Hair loss, Skin Dryness, Hoarseness of voice, Cold Intolerance, Slowed Movement, Difficulty concentration and poor memoryTimepoint: day zero to day 15 to day 30 to day 45 to day 60 to day 75 to day 90;Stabilization or reduction of Thyroxine doseTimepoint: day zero to day 90 | — |
Countries
India
Contacts
Public ContactShefali Thakkar
Arelang Naturals Pvt. Ltd.
Outcome results
None listed