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
1 other identifier
interventional
136
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedStudy Start
First participant enrolled
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2021
CompletedJune 1, 2021
May 1, 2021
3.1 years
February 23, 2018
May 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in incontinence episode per 24 h
assessed by 72 h bladder diary
8 week (post-treatment) and 12 week (follow-up)
Secondary Outcomes (3)
Change in ICIQ-SF questionnaire
8 week (post-treatment) and 12 week (follow-up)
Change in I-QOL questionnaire
8 week (post-treatment) and 12 week (follow-up)
proportion of participants with more than 50% improvement in incontinence episodes per 24h
8 week (post-treatment)
Study Arms (4)
Chinese herb & acupuncture
EXPERIMENTALParticipants will take Yiqi Suoquan granule and receive acupuncture.
Chinese herb & sham acupuncture
ACTIVE COMPARATORParticipants will take Yiqi Suoquan granule and receive sham acupuncture.
Placebo & acupuncture
ACTIVE COMPARATORParticipants will take placebo granule and receive acupuncture.
Placebo & sham acupuncture
PLACEBO COMPARATORParticipants will take placebo granule and receive sham acupuncture.
Interventions
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.
Eligibility Criteria
You may qualify if:
- (1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary
You may not qualify if:
- (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ran Pang, MD
Guang'anmen hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 1, 2018
Study Start
March 14, 2018
Primary Completion
April 18, 2021
Study Completion
April 18, 2021
Last Updated
June 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
The agreement for sharing IPD is not designed to be signed in informed consent form.