Trials Sponsors Conditions Drugs Pricing

Conditions

Urinary Incontinence

Keywords

Urinary incontinence, Chinese herb, Acupuncture

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

EXPERIMENTAL

Participants will take Yiqi Suoquan granule and receive acupuncture.

Combination Product: Chinese herb & sham acupunctureCombination Product: Placebo & acupunctureOther: Placebo & sham acupuncture

Chinese herb & sham acupuncture

ACTIVE COMPARATOR

Participants will take Yiqi Suoquan granule and receive sham acupuncture.

Combination Product: Chinese herb & acupunctureCombination Product: Placebo & acupunctureOther: Placebo & sham acupuncture

Interventions

Chinese herb & acupunctureCombination product

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.

Also known as: Yiqi Suoquan granule & acupuncture

Chinese herb & sham acupuncturePlacebo & acupuncturePlacebo & sham acupuncture

Eligibility Criteria

Age18 Years - 65 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Otherlead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Study Officials

Ran Pang, MD
Guang'anmen hospital
PRINCIPAL INVESTIGATOR

Enrollment

136 participants (actual enrollment reported by the registry).

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

Actual (reported)

Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

Chinese herb & acupuncture

Chinese herb & sham acupuncture

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo & acupuncture

Placebo & sham acupuncture

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

Chinese herb & acupuncture

Chinese herb & sham acupuncture

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo & acupuncture

Placebo & sham acupuncture

Data Sharing

Source record

Locations