Does Melatonin improve sleep quality after total knee arthroplasty?

Efficacy of Melatonin in improving sleep quality following primary TKA- an RCT - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090040

Enrollment

200

Registered

2025-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Tab. Melatonin 3mg, once daily at night (HS), for 3 months duration: Tab. Melatonin 3mg, once daily at night (HS), for 3 months duration Control Intervention1: Placebo: Placebo tablet f

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing primary TKA for osteoarthritis of the knee

Exclusion criteria

Exclusion criteria: Revision TKA, Unicompartmental TKA, History of substance abuse, previous history of any sleep disorders, previous history of anxiolytic of sleep medications

Design outcomes

Primary

Measure	Time frame
Sleep quality assessment using Epworth sleepiness score (ESS), Pittsburgh sleep quality index (PSQI), and PROMIS scoreTimepoint: 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks post-surgery	—

Secondary

Measure	Time frame
Any adverse events or complications associated with Melatonin useTimepoint: 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks post-surgery	—

Countries

India

Contacts

Public ContactTarun Jayakumar

Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals

tarunjaykumar@gmail.com9663365766

Outcome results

None listed

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