Intradialytic HypotensionPhase 2/3NCT05517993
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension
A Phase 2/3 study testing Gui-Lu-Er-Xian-Jiao-Wan in people with Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- Gui-Lu-Er-Xian-Jiao-Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal disease treated with hemodialysis for ≥3 months
- Receive a standard thrice-weekly hemodialysis schedule
- More than 25% of hemodialysis sessions complicated by intradialytic hypotension
Who cannot join
- Active malignancy
- Life-threatening conditions
- Pregnancy
- Recent participation in another clinical trial for intradialytic hypotension
- History of hypersensitivity or contraindication to herbal medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.
- Conditions
- Intradialytic Hypotension
- Being tested
- Gui-Lu-Er-Xian-Jiao-Wan
- Keywords
- Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gui-Lu-Er-Xian-Jiao-WanDrug
Also called GLEXJW
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks. Receives: Drug: Gui-Lu-Er-Xian-Jiao-Wan |
| Group B | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic hypotension episode
Hypotension episode during hemodialysis
Measured: Each time of dialysis during 12-weeks study period.
Secondary outcomes (2)
Early termination of hemodialysis
The episode of early termination in hemodialysis due to hypotension
Measured: Each time of dialysis during 12-weeks study period.
SF-36
Short Form (36) Health Survey (SF-36)
Measured: Baseline, 12 weeks, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Ting Liu, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517993
- Sponsor's protocol ID
- CMRPG8M0841
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
- ClinicalTrials.gov ID
- NCT05517993
- Acronym / sponsor ID
- CMRPG8M0841
- Conditions
- Intradialytic Hypotension
- Keywords
- Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Aug 2022 (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.
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Gui-Lu-Er-Xian-Jiao-WanGui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks. |
| Group B | No intervention | –No intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End stage renal disease treated with hemodialysis for ≥3 months
- Receive a standard thrice-weekly hemodialysis schedule
- More than 25% of hemodialysis sessions complicated by intradialytic hypotension
Key exclusion criteria (5 listed)
- Active malignancy
- Life-threatening conditions
- Pregnancy
- Recent participation in another clinical trial for intradialytic hypotension
- History of hypersensitivity or contraindication to herbal medicine
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 |
|---|---|---|
| Gui-Lu-Er-Xian-Jiao-WanAlso: GLEXJWGui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry. | Drug | Group A |
Primary outcome
Intradialytic hypotension episode
Time frame: Each time of dialysis during 12-weeks study period.
Hypotension episode during hemodialysis
2 secondary outcomes
Early termination of hemodialysis
Time frame: Each time of dialysis during 12-weeks study period.
SF-36
Time frame: Baseline, 12 weeks, 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Chun-Ting Liu principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gui-Lu-Er-Xian-Jiao-Wan in people with Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Ting Liu (+88677317123, juntin0214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intradialytic hypotension episode (time frame: Each time of dialysis during 12-weeks study period.). 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 26 Aug 2022.