Exploring use of melatonin in patients with inability to sleep after knee surgery

A Phase 4 open, single-arm, pilot study to evaluate the effectiveness and tolerability of a 4-week flexible dose regimen of Melatonin (5-10mg/day) and cognitive behavioural therapy for insomnia (CBT-I) for improving sleep quality and quantity and patient-reported outcomes in Post-Total Knee Arthroplasty/Replacement Adult Patients - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085471

Enrollment

Registered

2025-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Melatonin: 5-10mg/day for 4 weeks Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants who have undergone unilateral Total Knee Arthroplasty (TKA) for primary knee osteoarthritis. 2. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol 3. Participants who, in the investigator s opinion, are medically stable at the time of study intervention administration. 4. Participants with chronic, stable medical conditions (e.g., diabetes mellitus, hypertension, or cardiac disease) can participate if the investigator considers them medically stable.

Exclusion criteria

Exclusion criteria: 1. Not willing to participate or give consent. 2. Diagnosis other than primary osteoarthritis for TKA. 3. Patients with severe psychiatric disorders, severe sleep apnoea, or those currently on sleep medication. 4. Take opioids within six months before surgery. 5. Renal or hepatic disorders affecting melatonin metabolism.

Design outcomes

Primary

Measure	Time frame
To evaluate sleep quality using Pittsburgh Sleep Quality Index (PSQI)Timepoint: 1. baseline 2. 4 weeks	—

Secondary

Measure	Time frame
to evaluate Patient-Reported Outcomes Measurements (PROMs) (veterans rand 12 mental component score V-12 MCS & visual analog scale VAS for pain, morphine milligram equivalents prescribed, medication compliance, adverse events, and 4-week readmissions.Timepoint: 1. baseline 2. 4 weeks	—

Countries

India

Contacts

Public ContactDr Akash Saraogi

Saraogi Healthcare

saraogiakash@gmail.com9967357178

Outcome results

None listed

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