High Altitude PolycythemiaPhase 2/3NCT06082583
The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
A Phase 2/3 study testing Remote Ischemic Conditioning and Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) in people with High Altitude Polycythemia, run by Capital Medical University.
Trial summary
A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Altitude Polycythemia
- What is being tested?
- Remote Ischemic Conditioning and Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high-altitude polycythemia aging 18 to 65 years.
Who cannot join
- Allergic to Tibetan medicine ingredients;
- Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.
- Conditions
- High Altitude Polycythemia
- Being tested
- Remote Ischemic Conditioning, Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningDevice
Also called An electric auto-control device to perform remote ischemic conditioning.
Remote ischemic conditioning conducted by an electric auto-control device will be performed twice a day for 14 days, each session including 5-min ischemia and 5-min reperfusion.
Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)Drug
Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily.
| Study group | Role | What they receive |
|---|---|---|
| Tibetan Medicine Group | Active comparator | Not described Receives: Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) |
| Tibetan Medicine-Remote Ischemic Conditioning Group | Experimental | Not described Receives: Device: Remote Ischemic Conditioning; Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of effective treatment
The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.
Measured: Baseline and 1 month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude PolycythemiaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082583
- Sponsor's protocol ID
- HAPC
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
- ClinicalTrials.gov ID
- NCT06082583
- Acronym / sponsor ID
- HAPC
- Conditions
- High Altitude Polycythemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibetan Medicine Group | Active comparator | Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) |
| Tibetan Medicine-Remote Ischemic Conditioning Group | Experimental | Device: Remote Ischemic Conditioning, Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with high-altitude polycythemia aging 18 to 65 years.
Key exclusion criteria (2 listed)
- Allergic to Tibetan medicine ingredients;
- Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.
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 |
|---|---|---|
| Remote Ischemic ConditioningAlso: An electric auto-control device to perform remote ischemic conditioning.Remote ischemic conditioning conducted by an electric auto-control device will be performed twice a day for 14 days, each session including 5-min ischemia and 5-min reperfusion. | Device | Tibetan Medicine-Remote Ischemic Conditioning Group |
| Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily. | Drug | Tibetan Medicine Group, Tibetan Medicine-Remote Ischemic Conditioning Group |
Primary outcome
The incidence of effective treatment
Time frame: Baseline and 1 month after treatment.
The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for High Altitude Polycythemia
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High-Altitude Polycythemia Study
High-altitude Polycythemia, HAPC
Not yet recruitingPhase 3
Remote Ischemic Conditioning for High Altitude Polycythemia in High-Altitude Immigrant Populations
High Altitude Polycythemia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Remote Ischemic Conditioning and Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill) in people with High Altitude Polycythemia, run by Capital Medical University.
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 2 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Yuan Wang, M.D. (+86-135 8156 7815, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of effective treatment (time frame: Baseline and 1 month after treatment.). 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 13 Oct 2023.