Health TrialsbyHealthPanel

Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDongzhimen Hospital, Beijing

About this trial

This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inpatients diagnosed with acute ischemic stroke.

Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.

Acute ischemic stroke within 7 days after onset.

6 ≤ NIHSS <20.

Disqualifiers

Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.

NIHSS Ⅰa ≥2.

Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )

Received or planned thrombolysis or endovascular therapy after onset.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-dose Xinglou Chengqi granules

    Drug

    Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

  • Low-dose Xinglou Chengqi granules and placebo

    Drug

    Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High-dose groupExperimental treatment 1 intervention
Group B: Low-dose groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change of NIHSS score from baseline to day 14.

The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.

Time frame
Baseline and Day 14.

Secondary outcomes

1

The proportions of patients with mRS ≤ 2 or mRS ≤ 1.

The proportions of patients with modified Rankin Scale (mRS) ≤ 2 or mRS ≤ 1 will be analyzed between groups.

Time frame
Day 30, Day 60 and Day 90.
2

The change of NIHSS score

The change of NIHSS score will be analyzed at days 7, 30, 60, and 90.

Time frame
Day 7, day 30, day 60, day 90.
3

The proportion of patients with Barthel Index score ≥ 95 or ≥ 75.

The proportion of patients with Barthel Index score ≥ 95 or ≥ 75 will be analyzed at days 7, 14, 30, 60, and 90.

Time frame
day 7, day 14, day 30, day 60, day 90.
4

The change of EQ-5D score.

The change of EQ-5D score from baseline to days 7, 14, 30, 60, and 90 will be analyzed between groups.

Time frame
day 7, day 14, day 30, day 60, day 90.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongzhimen Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: