## Protocol Section
### Identification Module
**NCT ID:** NCT06430307

**Brief Title:** Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism

**Official Title:** A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism

#### Organization Study ID Info
**ID:** 2022014P7A01
#### Organization
**Class:** OTHER
**Full Name:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Quan Jiang

#### Responsible Party

**Investigator Affiliation:** Guang'anmen Hospital of China Academy of Chinese Medical Sciences

**Investigator Full Name:** Quan Jiang

**Investigator Title:** chief physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism.

### Conditions Module

**Conditions:**

- Postpartum Rheumatism

**Keywords:**

- Saussurea Involucrata Liquid Tonic

- Traditional Chinese Medicine

- Postpartum Rheumatism

### 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:** 128

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.

**Intervention Names:**

- Drug: Saussurea Involucrata Liquid Tonic

**Label:** Saussurea Involucrata Liquid Tonic

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** placebo of Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.

**Intervention Names:**

- Drug: Saussurea Involucrata Liquid Tonic

**Label:** placebo of Saussurea Involucrata Liquid Tonic

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Saussurea Involucrata Liquid Tonic

- placebo of Saussurea Involucrata Liquid Tonic

**Description:** This product is a single preparation of Saussurea Involucrata Liquid Tonic. It is used for rheumatoid arthritis, rheumatoid arthritis and dysmenorrhea caused by insufficient kidney yang and cold-damp stasis.

**Name:** Saussurea Involucrata Liquid Tonic

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.

**Measure:** VAS (visual analog scale)

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** the MOS item short from health survey, SF-36

**Measure:** SF-36

**Time Frame:** 8 weeks

**Description:** Hospital Anxiety and Depression Scale

**Measure:** HADS

**Time Frame:** 8 weeks

**Description:** Stanford Health Assessment Questionnaire

**Measure:** HAQ

**Time Frame:** 8 weeks

**Description:** Visual Analogue Score

**Measure:** VAS

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations
* Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome.
* Age 18-50
* Pain VAS score ≥4cm

Exclusion Criteria:

* Those in the puerperium (within 42 days after delivery).
* Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy.
* Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count \< 3.0×109/L, or hemoglobin \< 90 g/L, or platelet count \< 100.0×109/L in routine blood examination
* Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc.
* Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks.
* Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution.
* Existing or past history of cancer.
* Those who have participated in other clinical drug studies in the past 2 months.
* Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: HIGH

- As Found: Rheumatism

- ID: M6323

- Name: Collagen Diseases

- Relevance: HIGH

- As Found: Rheumatism

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003095

- Term: Collagen Diseases

### Misc Info Module

- Version Holder: 2024-05-31
