NCT04471298

A Study of Qishenyiqi Dripping Pills in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Evaluate the Safety and Tolerability of Continuous Oral Treatment With Qishenyiqi Dripping Pills in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy participants, following oral administration with multiple escalating dose of it.

Detailed description

Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and pain relief. This study is a randomized, double-blind, placebo-controlled, dose-escalation design study, including three cohorts and 36 healthy participants. Within each cohort, participant will receive Qishenyiqi dripping pills at the selected dose level by oral administration three times a day for 28 consecutive days.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Qishenyiqi dripping pills, 6 bags	28 consecutive days
DRUG	Qishenyiqi dripping pills, 9 bags	28 consecutive days
DRUG	Qishenyiqi dripping pills, 12 bags	28 consecutive days
DRUG	Qishenyiqi dripping pills placebo, 6 bags	28 consecutive days
DRUG	Qishenyiqi dripping pills placebo, 9 bags	28 consecutive days
DRUG	Qishenyiqi dripping pills placebo, 12 bags	28 consecutive days

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2020-07-15
• Last updated: 2021-07-14

Locations

1 site across 1 country: China