Evaluate the Effects of PBS-60 in Improving Muscle Strength and Functional Mobility in patients Undergoing total Knee replacement.

A Randomized Open-labeled Controlled Study to Evaluate the Effects of PBS-60 in Improving Muscle Strength and Functional Mobility in Subjects Undergoing Total Knee Arthroplasty (TKA) - NA

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094683

Enrollment

Registered

2025-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: M235- Chronic instability of knee

Interventions

Intervention1: PBS-60: Route-Oral, Dose-30 g/day with water/buttermilk/ milk or mix/sprinkle to food,Frequency-TID,Duration-42 days. Control Intervention1: Standard Of Treatment: The comparator arm pa

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male and female volunteers aged between 50-70 years. 2) Individuals scheduled for primary unilateral TKA. 3) Individuals with hematology and serum biochemistry within normal limits 4) Participants who demonstrate willingness to follow study procedures and meet all requirements. 5) Individuals who are prepared to participate in the study and provide informed consent.

Exclusion criteria

Exclusion criteria: 1)History of invasive lower extremity surgery within the last 5 years. 2)Known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorders. Allergy to soy, wheat or pea products. 3)Body Mass Index (BMI) greater than 18.5 to 29.9 kg /m . 4)Currently adhering to a restrictive weight-loss diet. 5)Known overt cardiovascular or metabolic disorders, such as heart disease or heart failure. 6)Any known/established gastrointestinal surgeries which may interfere with the nutrient absorption 7)Diagnosed with uncontrolled type 2 diabetes or hypertension. 8)Any physical/psychological condition that interferes with performing post-surgery rehabilitation. 9)Active malignancies or other systemic conditions deemed inappropriate for the study by the investigator. 10)Pregnant or breastfeeding women. 11)Individuals with psychiatric disorders that may interfere with participation.

Design outcomes

Primary

Measure	Time frame
To evaluate the impact of PBS - 60 on improving muscle strength and functional mobility in individuals undergoing TKA.Timepoint: Day 1 to Day 42	—

Secondary

Measure	Time frame
1) To evaluate the impact of PBS- 60 on pain intensity, and Knee Society Score (KSS) following TKA. 2) Occurrence of adverse events during the study period. Timepoint: Day 1 to Day 42	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Xplora Clinical Research Services Pvt. Ltd

hasan@xplorahealth.com09886012598

Outcome results

None listed

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