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Study aim: To assess the effectiveness of different acupuncture methods (manual, laser, acupoint embedding) combined with standard medication in reducing fatigue and improving specific biochemical markers in hypothyroidism patients. Design: This is a Phase III, four-arm, single‑blinded(assessor and analyst) randomized clinical trial involving 100 patients. Randomization: Permuted block randomization (blocks of 4 and 6), with allocation concealment via SNOSE envelopes. Arms: Manual Acupuncture (MA) + Levothyroxine (LT4): 2 times/week for 6 weeks Acupoint Embedding (AET) + LT4: 1 session Laser Acupuncture (LA) + LT4: 2 times/week for 6 weeks Control: LT4 only. Settings and conduct: Study Type: Phase III, randomized, four-arm clinical trial. Location: Acupuncture Clinic of Imam Reza Hospital, Mashhad, Iran. Patients: 100 patients with hypothyroidism. Randomization: Permuted block randomization method, SNOSE envelopes. Groups: MA, AET, LA, control (Levothyroxine only). Intervention Period: 6 weeks. Blinding: Assessors, laboratory personnel, statistical analysts blinded. Patients and practitioners not blinded. Participants/Inclusion and exclusion criteria: Age 18-65, primary hypothyroidism, stable levothyroxine, normal TSH, severe fatigue (FSS≥4). Commitment to protocol and consent / Secondary/central hypothyroidism, history of thyroid cancer, pregnancy/lactation. Severe illnesses, specific medications (steroids, immunosuppressants...). Recent levothyroxine dose change, recent acupuncture/embedding/laser therapy. Coagulation/anticoagulation issues, skin problems, non-compliance. Intervention groups: MA + Standard: 12 MA sessions over 6 weeks + Levothyroxine AET + Standard: 1 single AET session + Levothyroxine LA + Standard: 12 LA sessions over 6 weeks + Levothyroxine Control: Levothyroxine only Main outcome variables: Primary : Mean change in FSS Secondary: TSH, T4, NLR, PLR, SII, lipid profile, TyG , FBS, QoL
IRCTID: IRCT20121228011912N10
  1. Study the effect of combination therapy with levothyroxine and leiothyronine in comparison with levothyroxine on Well-Being, Quality of Life, or Cognitive Function in Patients with Primary Hypothyroidism
  2. Formulation of Levothyroxine plus slow-release Liothyronine preparation for treatment of hypothyroidism (Clinical trial Phase 2& 3)
  3. Randomized control Clinical Trial to assess the efficacy of the three different combined preparations of levothyroxine plus slow-release liothyronine
  4. Assessment of standard diet and Embedding Therapy on Anthropometric Indices, Ghrelin Levels , and Bioelectrical Impedance Analysis parameters in overweight and simple obesity individuals.
  5. Evaluation of the effect of adding vitamin C supplementation to Levothyroxine compared with Levothyroxine alone on laboratory parameters and clinical symptoms in patients with primary hypothyroidism: A randomized, placebo-controlled pilot clinical trial
  6. The effect of vitamin C supplementation on thyroid function in patients with primary hypothyroidism
  7. Comparing the effect of monotherapy with L-levothyroxine compared to combination therapy with L-levothyroxine and L-triiodothyronine on lipid profile of hypothyroid patients
  8. Effect of probiotics on thyroid function and fatigue score in patients with hypothyroidism
  9. Comparison of the clinical and immunological effectiveness of laser acupuncture, manual acupuncture, and sham in the treatment of knee osteoarthritis
  10. Non-inferiority Randomized Controlled Clinical Trial of the hormonal responses to Levothyroxin made by Aburaihan company and Levothyroxine made by Merck company
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