Postpartum RheumatismPhase 4NCT06430307
Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism
A Phase 4 study testing Saussurea Involucrata Liquid Tonic in people with Postpartum Rheumatism, run by Quan Jiang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Rheumatism
- What is being tested?
- Saussurea Involucrata Liquid Tonic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism
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
- Postpartum Rheumatism
- Being tested
- Saussurea Involucrata Liquid Tonic
- Keywords
- Saussurea Involucrata Liquid Tonic, Traditional Chinese Medicine, Postpartum Rheumatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saussurea Involucrata Liquid TonicDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Saussurea Involucrata Liquid Tonic | Experimental | Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks. Receives: Drug: Saussurea Involucrata Liquid Tonic |
| placebo of Saussurea Involucrata Liquid Tonic | Placebo comparator | 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. Receives: Drug: Saussurea Involucrata Liquid Tonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visual analog scale)
The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.
Measured: 8 weeks
Secondary outcomes (4)
SF-36
the MOS item short from health survey, SF-36
Measured: 8 weeks
HADS
Hospital Anxiety and Depression Scale
Measured: 8 weeks
HAQ
Stanford Health Assessment Questionnaire
Measured: 8 weeks
VAS
Visual Analogue Score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum RheumatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430307
- Sponsor's protocol ID
- 2022014P7A01
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism
- ClinicalTrials.gov ID
- NCT06430307
- Acronym / sponsor ID
- 2022014P7A01
- Conditions
- Postpartum Rheumatism
- Keywords
- Saussurea Involucrata Liquid Tonic, Traditional Chinese Medicine, Postpartum Rheumatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Quan JiangUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saussurea Involucrata Liquid Tonic | Experimental | Drug: Saussurea Involucrata Liquid TonicSaussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks. |
| placebo of Saussurea Involucrata Liquid Tonic | Placebo comparator | Drug: Saussurea Involucrata Liquid Tonicplacebo 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saussurea Involucrata Liquid TonicThis 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. | Drug | Saussurea Involucrata Liquid Tonic, placebo of Saussurea Involucrata Liquid Tonic |
Primary outcome
VAS (visual analog scale)
Time frame: 8 weeks
The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.
4 secondary outcomes
SF-36
Time frame: 8 weeks
HADS
Time frame: 8 weeks
HAQ
Time frame: 8 weeks
VAS
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saussurea Involucrata Liquid Tonic in people with Postpartum Rheumatism, run by Quan Jiang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (visual analog scale) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.