Urinary IncontinencePhase 2NCT03450902
Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence
A Phase 2 study testing Chinese herb & acupuncture in people with Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Chinese herb & acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2018to 18 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence
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.
Read the 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
- Being tested
- Chinese herb & acupuncture, Chinese herb & sham acupuncture, Placebo & acupuncture, Placebo & sham acupuncture
- Keywords
- Urinary incontinence, Chinese herb, Acupuncture
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herb & acupunctureCombination product
Also called Yiqi Suoquan granule & 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.
Chinese herb & sham acupunctureCombination product
Also called Yiqi Suoquan granule & 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.
Placebo & acupunctureCombination product
Also called placebo granule & 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.
Placebo & sham acupunctureOther
Also called placebo granule & 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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese herb & acupuncture | Experimental | Participants will take Yiqi Suoquan granule and receive acupuncture. Receives: Combination Product: Chinese herb & sham acupuncture; Combination Product: Placebo & acupuncture; Other: Placebo & sham acupuncture |
| Chinese herb & sham acupuncture | Active comparator | Participants will take Yiqi Suoquan granule and receive sham acupuncture. Receives: Combination Product: Chinese herb & acupuncture; Combination Product: Placebo & acupuncture; Other: Placebo & sham acupuncture |
| Placebo & acupuncture | Active comparator | Participants will take placebo granule and receive acupuncture. Receives: Combination Product: Chinese herb & acupuncture; Combination Product: Chinese herb & sham acupuncture; Other: Placebo & sham acupuncture |
| Placebo & sham acupuncture | Placebo comparator | Participants will take placebo granule and receive sham acupuncture. Receives: Combination Product: Chinese herb & acupuncture; Combination Product: Chinese herb & sham acupuncture; Combination Product: Placebo & acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incontinence episode per 24 h
assessed by 72 h bladder diary
Measured: 8 week (post-treatment) and 12 week (follow-up)
Secondary outcomes (3)
Change in ICIQ-SF questionnaire
assessed by ICIQ-SF questionnaire
Measured: 8 week (post-treatment) and 12 week (follow-up)
Change in I-QOL questionnaire
assessed by I-QOL questionnaire
Measured: 8 week (post-treatment) and 12 week (follow-up)
proportion of participants with more than 50% improvement in incontinence episodes per 24h
assessed by 72 h bladder diary
Measured: 8 week (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start14 Mar 2018
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Pang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Ran Pang, MD, Principal investigator, Guang'anmen hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450902
- Sponsor's protocol ID
- Z161100000516156
- Status last verified
- May 2021
- First submitted
- 23 Feb 2018
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The agreement for sharing IPD is not designed to be signed in informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03450902
- Acronym / sponsor ID
- Z161100000516156
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, Chinese herb, Acupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chinese herb & acupuncture | Experimental | Combination Product: Chinese herb & sham acupuncture, Combination Product: Placebo & acupuncture, Other: Placebo & sham acupunctureParticipants will take Yiqi Suoquan granule and receive acupuncture. |
| Chinese herb & sham acupuncture | Active comparator | Combination Product: Chinese herb & acupuncture, Combination Product: Placebo & acupuncture, Other: Placebo & sham acupunctureParticipants will take Yiqi Suoquan granule and receive sham acupuncture. |
| Placebo & acupuncture | Active comparator | Combination Product: Chinese herb & acupuncture, Combination Product: Chinese herb & sham acupuncture, Other: Placebo & sham acupunctureParticipants will take placebo granule and receive acupuncture. |
| Placebo & sham acupuncture | Placebo comparator | Combination Product: Chinese herb & acupuncture, Combination Product: Chinese herb & sham acupuncture, Combination Product: Placebo & acupunctureParticipants will take placebo granule and receive sham acupuncture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herb & acupunctureAlso: Yiqi Suoquan granule & acupunctureParticipants 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, Placebo & acupuncture, Placebo & sham acupuncture |
| Chinese herb & sham acupunctureAlso: Yiqi Suoquan granule & sham acupunctureParticipants 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 | Chinese herb & acupuncture, Placebo & acupuncture, Placebo & sham acupuncture |
| Placebo & acupunctureAlso: placebo granule & acupunctureParticipants 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. | Combination product | Chinese herb & acupuncture, Chinese herb & sham acupuncture, Placebo & sham acupuncture |
| Placebo & sham acupunctureAlso: placebo granule & sham acupunctureParticipants 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 | Chinese herb & acupuncture, Chinese herb & sham acupuncture, Placebo & acupuncture |
Primary outcome
Change in incontinence episode per 24 h
Time frame: 8 week (post-treatment) and 12 week (follow-up)
assessed by 72 h bladder diary
3 secondary outcomes
Change in ICIQ-SF questionnaire
Time frame: 8 week (post-treatment) and 12 week (follow-up)
Change in I-QOL questionnaire
Time frame: 8 week (post-treatment) and 12 week (follow-up)
proportion of participants with more than 50% improvement in incontinence episodes per 24h
Time frame: 8 week (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No. The agreement for sharing IPD is not designed to be signed in informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Pang, MD principal investigator
Guang'anmen hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese herb & acupuncture in people with Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incontinence episode per 24 h (time frame: 8 week (post-treatment) and 12 week (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.