Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether combination therapy with Chinese herbal
      formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed
      urinary incontinence.
    

Detailed description: 
      This factorial, randomized, controlled trial is aimed to assess the effectiveness of
      combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the
      treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly
      allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi
      Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham
      acupuncture.

      To minimize the evaluation bias, the outcome assessors and statisticians will be masked to
      treatment allocation besides participants.
    

Intervention name(s): Chinese herb & acupuncture; Chinese herb & sham acupuncture; Placebo & acupuncture; Placebo & sham acupuncture
Intervention type(s): Combination Product; Combination Product; Combination Product; Other
Intervention description(s): Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.; Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.; Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.; Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.
Other intervention name(s): Yiqi Suoquan granule & acupuncture; Yiqi Suoquan granule & sham acupuncture; placebo granule & acupuncture; placebo granule & sham acupuncture
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urinary incontinence, Chinese herb, Acupuncture