Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill

NCT ID: NCT04029701

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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Many years of clinical practice experience has found that Ruyi treasure pill can be used to treat nerve meridian injury caused by cerebrovascular disease, but in the end, the clinical efficacy is still lacking systematic clinical evidence-based medical research data. Based on this, the clinical observation of Ruyi treasure pill in the treatment of post-stroke motor and sensory dysfunction was carried out to verify its clinical location, to provide evidence for the application of clinical subdivision of later products and two development of products, and to publish academic papers on the expected research results.

Detailed Description

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Conditions

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Post-stroke Patients With Motor and Sensory Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This Trials is a randomly controlled, double-blinded and placebo-controlled trial.And the methodology team of Guangdong Provincial Hospital of Chinese Medicine is responsible for the editing of blindness.

Study Groups

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Research group

Subjects who are recruited into this group are asked to take the Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment.

P.S. Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Group Type EXPERIMENTAL

Ruyizhenbao Pill

Intervention Type DRUG

Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Control group

Subjects who are recruited into this group are asked to take the placebo of Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment.

P.S. Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.,which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Group Type PLACEBO_COMPARATOR

Placebo of Ruyizhenbao Pill

Intervention Type DRUG

Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.,which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Interventions

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Ruyizhenbao Pill

Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Intervention Type DRUG

Placebo of Ruyizhenbao Pill

Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.,which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.

Intervention Type DRUG

Other Intervention Names

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Research group Control group

Eligibility Criteria

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Inclusion Criteria

1. Compliance with stroke diagnostic criteria;
2. The course of the disease is 15 days to 6 months;
3. People who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment;
4. Age 20 to 80 years old;
5. Sign an informed consent and participate voluntarily in the study.

Exclusion Criteria

1. Diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination;
2. Combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.;
3. Those who are not aware or concoced due to more severe cognitive impairment and complete aphasia;
4. People who are allergic to the drug or are allergic to multiple medications.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongxia Chen, Master

Role: CONTACT

020-39318381 ext. 02081887233

Ruihuan Pan, Dotor

Role: CONTACT

020-39318381

Facility Contacts

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Ruihuan Pan

Role: primary

02039318381 ext. 02039318381

Shanshan Ling, Master

Role: backup

020-39318381

References

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Ling SS, Pan RH, Zhan LC, Li M, Yang ZJ, Yang HD, Chen HX. Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke: A Double-Blinded, Randomized Placebo-Controlled Clinical Trial. Chin J Integr Med. 2022 Oct;28(10):872-878. doi: 10.1007/s11655-022-3577-9. Epub 2022 Jun 20.

Reference Type DERIVED
PMID: 35723814 (View on PubMed)

Other Identifiers

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2017-K-38

Identifier Type: -

Identifier Source: org_study_id

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