NCT03450902

Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Chinese herb & acupuncture	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.
COMBINATION_PRODUCT	Chinese herb & sham acupuncture	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.
COMBINATION_PRODUCT	Placebo & acupuncture	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.
OTHER	Placebo & sham acupuncture	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.

Timeline

• Start date: 2018-03-14
• Primary completion: 2021-04-18
• Completion: 2021-04-18
• First posted: 2018-03-01
• Last updated: 2021-06-01

Locations

1 site across 1 country: China