Effects of Shuganjianpihuatanxingqi decoction on mild subclinical hypothyroidism: A SPIRIT compliant randomized controlled trial study protocol

INTRODUCTION: Mild subclinical hypothyroidism (SCH) can cause depression, fatigue, cognitive dysfunction, or other hypothyroid symptoms, and even progress to hypothyroidism. The treatment of mild SCH is controversial. Shuganjianpihuatanxingqi decoction (SD) is a frequently prescribed Chinese herbal medicine in patients with mild SCH. However, scientific evidence is needed to confirm the therapeutic effect of SD. METHODS AND ANALYSIS: This study is a randomized, double-blind, and controlled clinical trial. A total of 228 participants with the diagnosis of mild SCH will be randomly assigned to the SD or placebo group in a ratio of 1:1. Participants will receive treatment for 12 weeks and undergo 12-month follow-up. The primary outcome measure is the thyroid-stimulating hormone level, and secondary outcomes will be the differences in the results of Thyroid-related Quality of Life Questionnaire, blood lipids, and Traditional Chinese Medicine Symptom Score Scale between baseline and at 12 weeks after intervention. ETHICS AND DISSEMINATION: The study has been approved by Guang’anmen Hospital of China Academy of Chinese Medical Sciences (no.2018-005-ky-01). The trial results will be published via peer-reviewed journals and the Clinical Research Information Service. TRIAL REGISTRATION NUMBER: ChiCTR1800015781 (approval date: 20 April 2018).