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Based on metabolomics analysis, the method of strengthening spleen, tonifying kidney, and promoting blood circulation is used to treat rheumatoid arthritis with muscle wasting and osteoporosis

Based on metabolomics analysis, the method of strengthening spleen, tonifying kidney, and promoting blood circulation is used to treat rheumatoid arthritis with muscle wasting and osteoporosis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106729
Enrollment
Unknown
Registered
2025-07-29
Start date
2022-07-12
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis with muscle loss - osteoporosis

Interventions

Treatment group:Administer 10mg qw of methotrexate+70mg qw of alendronate sodium vitamin D+traditional Chinese medicine compound for treatment
Control group:Administer 10mg qw of methotrexate+70mg qw of alendronate sodium vitamin D

Sponsors

Dongguan Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosis criteria of traditional Chinese medicine syndrome type: refer to the "2019 Guidelines for the Diagnosis and Treatment of Osteoporosis with Integrated Traditional Chinese and Western Medicine" and "2020 Guidelines for the Diagnosis and Treatment of Traditional Chinese Medicine for Rheumatoid Arthritis" The syndrome type is in line with the spleen and kidney yang deficiency and blood stasis type Main symptoms: joint tingling, cold pain in the waist and knees, loose stools after little appetite, and weakness in the limbs Secondary symptoms: fear of cold and warmth, abdominal distension, and yellowing of the complexion. Tongue image, pulse: tongue dark red, ecchymosis, thin white or white thick, greasy; The pulse is deep or thin. Western medicine diagnostic standards are based on: Diagnostic criteria for rheumatoid arthritis: Meets the 1987 American College of Rheumatology (ACR) or 2010 European League Against Rheumatism (EULAR) classification criteria for RA Diagnostic criteria for osteoporosis: Referring to the recommended diagnostic criteria for osteoporosis in Chinese, bone loss is diagnosed if BMD in one or more parts is 1.0 standard deviations below the normal peak bone of the same sex, and OP is diagnosed if it is 2.5 standard deviations below the normal peak of the same sex. Sarcopenia: Chinese expert consensus: the square ratio of skeletal muscle mass (kg) to height (m) of the limbs, i.e., SMI is lower than the average skeletal muscle mass of young adults of the same race by 2 standard deviations or BIA method is less than 7kg/m^2 for men and 5.7kg/m^2 for women; Inclusion Criteria: 1. Meet the above diagnostic criteria of traditional Chinese and Western medicine; 2. Age 20-80 years old; 3. Good compliance, able to receive treatment and various tests according to the norms.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and mentally ill patients; 2. Patients with other rheumatic diseases; 3. Other secondary osteoporosis; 4. Combined with severe malnutrition, or with severe damage to the heart, brain, kidney, and hematopoietic system.

Design outcomes

Primary

MeasureTime frame
Bone density;Traditional Chinese Medicine Syndrome Scoring;Limb skeletal muscle mass;

Countries

China

Contacts

Public ContactPeng Jianhong

Dongguan Traditional Chinese Medicine Hospital

90264280@qq.com+86 135 3835 3635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026