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Clinical trial on the safety and efficacy of wheat protein peptide in alleviating arthritis pain

Clinical trial on the safety and efficacy of wheat protein peptide in alleviating arthritis pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114321
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-06-11
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Arthritis

Interventions

Trial group:Take Vollapep2 plant water peptide.One sachet per time, once daily, take with 150ml of warm water.Take continuously for 45 days.
Control group:Take Vollapep2 plant water peptide without active ingredients.One sachet per time, once daily, take with 150ml of warm water.Take continuously for 45 days

Sponsors

Hefei Boe Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The subject must fully understand the purpose, procedures, and related requirements of this study, voluntarily sign an informed consent form, and indicate their willingness to participate in the study; 2. The subject's age should be between 18 and 65 years, with no gender restrictions; 3. The subject's diagnosis must strictly meet the Western medical diagnostic criteria for knee osteoarthritis as outlined in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)."; 4. At screening, the baseline pain score of the study-side knee on a 100-mm visual analog scale (VAS) (during activity: walking) should be between 40 mm and 80 mm, excluding 80 mm (>=40 mm and <80 mm); 5. From the screening period through the entire trial treatment period, the subject should avoid any non-habitual physical activity.

Exclusion criteria

Exclusion criteria: 1. The subject has had an open knee injury or undergone other knee surgeries (e.g., arthroscopy, arthroscopic debridement, knee replacement) within one year prior to screening; 2. The subject has received intra-articular drug injections (e.g., corticosteroids, hyaluronic acid, chitosan, growth factors, platelet-rich plasma) within three months prior to screening; 3. Subjects must not have used any medications for osteoarthritis (including analgesics, NSAIDs, slow-acting drugs for OA symptom relief, anti-neuropathic pain drugs, or Chinese patent medicines) within one week prior to randomization, except for rescue medications or low-dose aspirin (<=325 mg/day) for cardiovascular disease prevention; 4. Subjects must not have used anti-anxiety medications (e.g., duloxetine, doxepin, amitriptyline) within one month prior to randomization; 5. Subjects clinically diagnosed with gout or hyperuricemia; 6. Pregnant or lactating women, or those with plans to conceive within three months; 7. The investigator deems the subject unsuitable for other reasons.

Design outcomes

Primary

MeasureTime frame
100 mm visual analog scale (VAS);Quantitative Grading Standards for Syndromes;Health Assessment Questionnaire Index;WOMAC score for knee osteoarthritis;

Countries

China

Contacts

Public ContactLiu Yiming / Shen Dianhong

Hefei Boe Hospital

libo@lingkamedtech.com+86 551 6698 1666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026