Fibromyalgia SyndromeNCT06285045

Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression

A study testing Roujin Formula in people with Fibromyalgia Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia Syndrome
What is being tested?: Roujin Formula
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 1 Oct 2018to 31 Aug 2019
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for filbromyalgia;
2. Be over 18 years of age;
3. Sign informed consent.

Who cannot join

1.patients with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, ankylosing spondylitis and other rheumatic diseases ;
2.severe liver and kidney dysfunction;
3.severe cardiovascular and cerebrovascular diseases and other diseases ;
4.pregnant or lactating women ;
5.had taken drugs for the treatment of this disease in the last 4 weeks.

Trial locations and contacts

1 site in 1 country.

China1 site

Juan Jiao
Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: Randomized Controlled Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression

To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.

Conditions: Fibromyalgia Syndrome
Being tested: Roujin Formula
Keywords: Fibromyalgia syndrome, Blood deficiency and liver depression；, Roujin Formula, Clinical trial
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roujin FormulaDrug
48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.

Study groups in NCT06285045
Study group	Role	What they receive
Roujin Formula group	Experimental	Roujin Formula : angelica, bupleurum, radix paeoniae alba, etc. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks. Receives: Drug: Roujin Formula
Control group	No intervention	Placebo : According to the internationally accepted standard, one-tenth of the dose of Roujin Formula was used to prepare a placebo, which was similar to Roujin Formula in appearance, color, taste or smell, and packaging. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Measured: baseline,4 weeks, 8 weeks, 12 weeks
The change of the Visual Analogue Scale (VAS) for pain from baseline
Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.
Measured: baseline,4 weeks, 8 weeks, 12 weeks

Secondary outcomes (3)

The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Measured: baseline,4 weeks, 8 weeks, 12 weeks
The change of the Beck depression inventory(BDI) from baseline
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Measured: baseline,4 weeks, 8 weeks, 12 weeks
The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Measured: baseline,4 weeks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201831 Aug 2019

First posted29 Feb 2024
Study start1 Oct 2018
Primary completion31 Aug 2019
Study completion31 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fibromyalgia SyndromeStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06285045
Sponsor's protocol ID: 2060302-1703-05
Status last verified: Mar 2024
First submitted: 22 Feb 2024
Last updated: 5 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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All Fibromyalgia Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression
ClinicalTrials.gov ID: NCT06285045
Acronym / sponsor ID: 2060302-1703-05
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia syndrome, Blood deficiency and liver depression；, Roujin Formula, Clinical trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: 1 Oct 2018 (actual)
Primary completion: 31 Aug 2019 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 29 Feb 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Roujin Formula group	Experimental	Drug: Roujin FormulaRoujin Formula : angelica, bupleurum, radix paeoniae alba, etc. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.
Control group	No intervention	–Placebo : According to the internationally accepted standard, one-tenth of the dose of Roujin Formula was used to prepare a placebo, which was similar to Roujin Formula in appearance, color, taste or smell, and packaging. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for filbromyalgia;
2. Be over 18 years of age;
3. Sign informed consent.

Key exclusion criteria (5 listed)

1.patients with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, ankylosing spondylitis and other rheumatic diseases ;
2.severe liver and kidney dysfunction;
3.severe cardiovascular and cerebrovascular diseases and other diseases ;
4.pregnant or lactating women ;
5.had taken drugs for the treatment of this disease in the last 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
Roujin Formula48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.	Drug	Roujin Formula group

Primary outcome

The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Time frame: baseline,4 weeks, 8 weeks, 12 weeks
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
The change of the Visual Analogue Scale (VAS) for pain from baseline
Time frame: baseline,4 weeks, 8 weeks, 12 weeks
Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.

3 secondary outcomes

The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline
Time frame: baseline,4 weeks, 8 weeks, 12 weeks
The change of the Beck depression inventory(BDI) from baseline
Time frame: baseline,4 weeks, 8 weeks, 12 weeks
The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline
Time frame: baseline,4 weeks, 8 weeks, 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.

Related trials for Fibromyalgia Syndrome

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Roujin Formula in people with Fibromyalgia Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline (time frame: baseline,4 weeks, 8 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06285045.

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 5 Mar 2024.