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The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

Primary Purpose

High Altitude Polycythemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Remote Ischemic Conditioning
Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Altitude Polycythemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with high-altitude polycythemia aging 18 to 65 years. Exclusion Criteria: Allergic to Tibetan medicine ingredients; Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Tibetan Medicine Group

    Tibetan Medicine-Remote Ischemic Conditioning Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    The incidence of effective treatment
    The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082583
    Brief Title
    The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
    Official Title
    A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Capital Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Altitude Polycythemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tibetan Medicine Group
    Arm Type
    Active Comparator
    Arm Title
    Tibetan Medicine-Remote Ischemic Conditioning Group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Remote Ischemic Conditioning
    Other Intervention Name(s)
    An electric auto-control device to perform remote ischemic conditioning.
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)
    Intervention Description
    Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily.
    Primary Outcome Measure Information:
    Title
    The incidence of effective treatment
    Description
    The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment.
    Time Frame
    Baseline and 1 month after treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with high-altitude polycythemia aging 18 to 65 years. Exclusion Criteria: Allergic to Tibetan medicine ingredients; Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Wang, M.D.
    Phone
    +86-135 8156 7815
    Email
    wilma0106@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

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