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New treatment option for Bladder Pain Syndrome
Official title EA for BPS: An RCT and Study for Central Mechanism
ClinicalTrials.gov ID: NCT05279963
What this study is testing
What is Amitriptyline?
Amitriptyline is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for bladder pain syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized controlled and assessor-blinded design trial to evaluate the efficacy and safety of acupuncture for bladder pain syndrome(BPS). All eligible participants will be randomly assigned to the medication group(n=21), EA group(n=42) and SA group(n=21) in a 1:2:1 allocation ratio.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 18 ≤ age ≤70 years, male or female;
- Must fulfill the first and the second diagnostic criteria;
- 30 mm≤ VAS score ≤80mm;
- Participants can fully understand the study protocol and a written informed consent is signed.
You likely can't join if
- Patients with previous bladder stones or other space-occupying lesions;
- Previous positive urine culture or significant abnormal urine routine;
- Significant organic lesions of genitourinary system and pelvic organs;
- Patients suffer from severe primary diseases such as cardiovascular, cerebrovascular, respiratory, liver and kidney, or patients cannot receive EA...
- People with heart stents and other metallic substances in their bodies;
- Women who are pregnant, planning to become pregnant, breast-feeding or allergic to study drugs;
See the full eligibility criteria
- 18 ≤ age ≤70 years, male or female;
- Must fulfill the first and the second diagnostic criteria;
- 30 mm≤ VAS score ≤80mm;
- Participants can fully understand the study protocol and a written informed consent is signed.
- Patients with previous bladder stones or other space-occupying lesions;
- Previous positive urine culture or significant abnormal urine routine;
- Significant organic lesions of genitourinary system and pelvic organs;
- Patients suffer from severe primary diseases such as cardiovascular, cerebrovascular, respiratory, liver and kidney, or patients cannot receive EA treatment due to any reasons;
- People with heart stents and other metallic substances in their bodies;
- Women who are pregnant, planning to become pregnant, breast-feeding or allergic to study drugs;
- Patients have participated in other clinical trials within the last 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.