NCT06082583

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

September 21, 2023

Last Update Submit

October 8, 2023

Conditions

High Altitude Polycythemia

Outcome Measures

Primary Outcomes (1)

  • The incidence of effective treatment

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

    Baseline and 1 month after treatment.

Study Arms (2)

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 ConditioningDrug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)

Interventions

Remote Ischemic ConditioningDEVICE

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.

Also known as: An electric auto-control device to perform remote ischemic conditioning.
Tibetan Medicine-Remote Ischemic Conditioning Group
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.

Tibetan Medicine GroupTibetan Medicine-Remote Ischemic Conditioning Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with high-altitude polycythemia aging 18 to 65 years.

You may not qualify if:

  • Allergic to Tibetan medicine ingredients;
  • Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Medicine, Tibetan Traditional

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Central Study Contacts

Yuan Wang, M.D.

CONTACT

+86-135 8156 7815wilma0106@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 13, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share