Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD

NCT ID: NCT04544722

Last Updated: 2021-03-01

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

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-06-01

Brief Summary

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This study will evaluate the safety and efficacy of Jianfei Kangfu Cao in the treatment of primary Sjogren's syndrome associated interstitial lung disease.

Detailed Description

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This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks.

1. Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
2. Blind method :The test process will be in a double-blind state.
3. Control drug: The lung rehabilitation training will be used as control in this trial.

Conditions

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Primary Sjogren's Syndrome Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Jianfei Kangfu Cao

The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.

Group Type EXPERIMENTAL

Jianfei Kangfu Cao

Intervention Type BEHAVIORAL

The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.

Lung rehabilitation training

The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Group Type ACTIVE_COMPARATOR

lung rehabilitation training

Intervention Type BEHAVIORAL

The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Interventions

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Jianfei Kangfu Cao

The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.

Intervention Type BEHAVIORAL

lung rehabilitation training

The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. According to the 2012 ACR classification of primary Sjogren's syndrome .
2. CT confirmed interstitial lung disease;
3. DLCO≧40%;
4. Stable treatment for at least 12 weeks;
5. Patients with good compliance should sign informed consent before the tria.

Exclusion Criteria

1. The patient is using or has used anti pulmonary fibrosis drugs;
2. Pulmonary infection, tumor and other connective tissue diseases;
3. Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis;
4. Patients with severe hypertension, diabetes and heart, liver and renal failure;
5. Women with reproductive needs;
6. Idiopathic pulmonary interstitial disease;
7. The researcher thinks that it is not suitable to participate in this experiment;
8. Participants in other clinical trials.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhujing Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Longhua Hospital

Jianchun Mao, Master

Role: STUDY_CHAIR

Longhua Hospital

Huanru Qu, Ph.D

Role: STUDY_CHAIR

Longhua Hospital

Locations

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Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhujing Zhu, Ph.D

Role: CONTACT

+8613816914874

Jianchun Mao, Master

Role: CONTACT

+8618917763231

Facility Contacts

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Jianchun Mao, master

Role: primary

86-18917763231

Other Identifiers

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Jianfei Kangfu Cao

Identifier Type: -

Identifier Source: org_study_id

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