## Protocol Section
### Identification Module
**NCT ID:** NCT00953979

**Brief Title:** Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis

**Official Title:** A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial

#### Organization Study ID Info
**ID:** 2008-2
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-01-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-01-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-09

**Type:** ACTUAL

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2012-01

#### Study First Post Date
**Date:** 2009-08-06
**Type:** ESTIMATED
**Study First Submit Date:** 2009-08-05
**Study First Submit QC Date:** 2009-08-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** China-Japan Friendship Hospital

**Class:** OTHER_GOV

**Name:** Dongguan People's Hospital

**Class:** OTHER

**Name:** Zhujiang Hospital

**Class:** OTHER

**Name:** Huashan Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Gu Jieruo

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Gu Jieruo

**Investigator Title:** Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.

### Conditions Module

**Conditions:**

- Ankylosing Spondylitis

- Treatment

**Keywords:**

- ankylosing spondylitis

- treatment

- Sulfasalazine

- kunxian capsule

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 126

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sulfasalazine is a drug in treatment RA, AS and ulcerative colonitis. In this study, Sulfasalazine is used to act as an active comparator to access the efficacy of kunxian capsule.

**Intervention Names:**

- Drug: kunxian capsule

**Label:** Sulfasalazine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The placebo capsule was used to be a comparator of kunxian capsule

**Intervention Names:**

- Drug: kunxian capsule

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sulfasalazine

- placebo

**Description:** The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.

**Name:** kunxian capsule

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** proportion of patients achieving ASAS20 response

**Time Frame:** 12th week

#### Secondary Outcomes

**Measure:** proportion of patients achieving BASDAI20/50/70 response

**Time Frame:** 12th week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 16 to 65 years old, having signed the informed consent;
* fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
* BASDAI score more than 4;
* stop taking DMARDs for at least 4 weeks;
* NSAIDs dosage has been stable for at least 4 weeks;

Exclusion Criteria:

* Intra-articular injection of cortisone within 3 months.
* History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
* Accompanied by fibromyalgia or other rheumatic diseases;
* Female of pregnancy or breast feeding;
* History of mental disease and poor compliance.
* History of drug abuse or alcoholism.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

**State:** Guangdong

**Zip:** 510630

#### Overall Officials

**Official 1:**

**Affiliation:** Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University

**Name:** Jieruo Gu, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Li Q, Li L, Bi L, Xiao C, Lin Z, Cao S, Liao Z, Gu J. Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial. Trials. 2016 Jul 22;17(1):337. doi: 10.1186/s13063-016-1438-6.

**PMID:** 27449221

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001850

- Term: Bone Diseases, Infectious

- ID: D000007239

- Term: Infections

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000089183

- Term: Axial Spondyloarthritis

- ID: D000025242

- Term: Spondylarthropathies

- ID: D000000844

- Term: Ankylosis

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15961

- Name: Spondylitis

- Relevance: HIGH

- As Found: Spondylitis

- ID: M23035

- Name: Spondylarthritis

- Relevance: HIGH

- As Found: Spondylitis

- ID: M15962

- Name: Spondylitis, Ankylosing

- Relevance: HIGH

- As Found: Ankylosing Spondylitis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5129

- Name: Bone Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2697

- Name: Axial Spondyloarthritis

- Relevance: LOW

- As Found: Unknown

- ID: M23036

- Name: Spondylarthropathies

- Relevance: LOW

- As Found: Unknown

- ID: M4170

- Name: Ankylosis

- Relevance: LOW

- As Found: Unknown

- ID: T5412

- Name: Spondylarthropathy

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013166

- Term: Spondylitis

- ID: D000025241

- Term: Spondylarthritis

- ID: D000013167

- Term: Spondylitis, Ankylosing

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M15280

- Name: Sulfasalazine

- Relevance: LOW

- As Found: Unknown

- ID: T318

- Name: Tripterygium

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
