To Evaluate the Safety and Efficacy of TD0015 Pilulae in Patients with Knee Osteoarthritis

NCT06657495 | Recruiting Phase 2

• 1 other identifier: TD0015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Preclinical trials in animal models have suggested that the estimated dose of TD0015 in clinical presents no safety concerns.The investigational product is TD0015 pilulae, which is based on the traditional prescription named "Độc hoạt tang ký sinh thang" (Thien Kim Phuong). The traditional prescription has the effect of circulating blood in the tendons and bones to bring out evil spirits, blood tonic, kidney tonic to prevent recurrence of diseases and against joint degeneration, joint deformation, muscle atrophy, stiffness to recover normal joint function.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Change from baseline on the Western Ontario and McMaster Universities Osteoarthrities Index) WOMAC to evaluate the level of symptoms

  WOMAC was scored by investigator in visits (T1, T2, T3, T4, T5) and compared with T0

  Day 15th, day 30th, day 45th, day 60th and day 30th after end of study

• Change from baseline in Pain Scores on the Visual Analog Scale

  VAS scale: 0 = no pain \| 0--\>2: mild \| 2--\>4: moderate \| 4--\> 6: severe \| 6-\>8: extreme \| 8--\>10: untolerable Evaluate outcome of treatment according to VAS scale: * Very Good: 0 * Good: 1 - 4 * Average: 5 - 7 * Weak: \>8

  day 15th, day 30th, day 45th, day 60th and day 30th after end of study

• Change in symptoms severity was reported by patient on the Lequesne Index

  Lequesne Index at prior and after treatment (day 15th, day 30th, day 45th, day 60th and day 30th after end of study).

  day 15th, day 30th, day 45th, day 60th and day 30th after end of study

• Percentage of patients taking rescue medication

  3 Arms were allowed to use oral NSAIDs (meloxicam 7,5 mg x 1-2 tablets/day) when pain was severe. All NSAIDs in the study need to be documented in detail

  90 days

• The average dose of rescue medication was used

  90 days

• Frequency of AE, SAE

  Reference CTCAE 4.03

  90 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo pilulae weighing 5g/pack, after a meal, 1pack/time x 2 times/day

Drug: TD0015 Placebo

Investigational product 1

EXPERIMENTAL

estimated dose:TD0015 pilulae weighing 5g/pack , after a meal, 1pack/time x 2 times/day

Drug: TD0015

Investigational product 2

EXPERIMENTAL

1.5 times of estimated dose: TD0015 pilulae weighing 7.5g/pack , after a meal, 1pack/time x 2 times/day

Drug: TD0015

Interventions

TD0015 DRUG

TD0015 is black, dark brown inside pilulae and has special smell of herbal, slightly sour then bitter taste.

Investigational product 1; Investigational product 2

TD0015 Placebo DRUG

Placebo was packed in pack 5g

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years old must meet ALL or the following criteria clusters 1,2,6 or 1,3,5,6 or 1,4,5,6 to be enrolled:
• Knee pain
• Bone spurs forming along the edges of the joint, narrowing of joint space in X-ray film (grade I-III) according to Kellgren and Lawrence
• Knee joint effusion
• Morning stiffness that lasts less than 30 minutes when moving
• Knee crepitus when moving
• Patient voluntarily agree and and sign in the ICF
• According to traditional medicine: The disease type is Wind-Cold-Damp Bi with Kidney and Liver Deficiency. Symptoms are knee joint is pain, cold and heavy. Pain is usually fixed, little movement, mild during the day, severe at night, increased in cold and wet weather. Warm compresses to relieve pain, knee joint may be swollen, limited movement, may have morning stiffness, joint deformity associated with muscle atrophy, back pain, not warm limbs.The tongue is pale, the tongue is white and greasy, and deep-thready-weak pulse.

You may not qualify if:

• Hypersensitivity to any subtances of TD0015 pilulae.
• Pregnant or lactating
• Currently having surgical indications.
• Other conditions asseted by the investigator that are not eligible to be enrolled.
• Knee Osteoarthritis grade IV according to classification of Kellgren and Lawrence (specify that large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends)
• Self-administration of other anti-inflammatory medicine (except for NSAIDs) during study period as for 3 arms
• Patient is treated by NSAIDs within 3 days or has corticosteroid Intra-articular injection within 3 months prior to enrolment
• Joint and/or systemic infections
• Cardiovascular diseases (arrhythmia, hypertension) without treatment
• Cross - hypertensitivity to aspirin or other NSAIDs
• History of recent or progressive peptic ulcer/gastrointestinal perforation
• Severe liver failure
• Severe renal failure without dialysis
• Gastrointestinal hemorrhage, recent brain hemorrhage or disorders causing systemic hemorrhage
• Uncontrolled heart failure

Sponsors & Collaborators

• Sao Thai Duong Joint Stock Company: lead
• Big Leap Research: collaborator

Study Sites (1)

National Hospital of Traditional Medicine

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (1)

• Ha NTT, Nghia DT, Nga HTV, Lua TT, Hong NTB, Hanh NT, Ngoc NK, Vuong NL. Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial. Integr Med Res. 2025 Jun;14(2):101143. doi: 10.1016/j.imr.2025.101143. Epub 2025 Mar 31.

  PMID: 40290409 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Hong Van Thi Nguyen, MSC

CONTACT

(+84)916451269; vannh@thaiduong.com.vn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three arms: basic dose, 1.5 basic dose and placebo

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 24, 2024
• Study Start: July 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)