A clinical Trial in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles. Clinical trial is to study efficacy, safety and tolerability of Amitriptyline 4% + Ketamine 2% Cream in comparison to Capsaicin Cream 0.025%, (reference product).

A comparative single blind, Parallel group, non-crossover, multi-centric clinical trial of Amitriptyline 4% + Ketamine 2 % Cream in patients having Neuralgia due to diabetes, chemotherapy or shingles.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000688

Enrollment

100

Registered

2009-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Neuralgia due to diabetes, chemotherapy or shingles Health Condition 2: G328- Other specified degenerative disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Amitriptyline 4% + Ketamine 2% Cream: twice daily to the areas of worst pain for 4 weeks Control Intervention1: Capsaicin Cream 0.025%: twice daily to the areas of worst pain for 4 week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. Patient with history, signs & symptoms of peripheral neuropathies due to diabetes, chemotherapy or shingles.

Exclusion criteria

Exclusion criteria: 1. Patients < 18 & > 60 years 2. History of hypersensitivity to the study drug or similar class of drug. 3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 4. Pregnant or lactating women. 5. Patients with serum creatinine greater than 2.5 mg/dl. 6. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 7. Significant history or presence of glaucoma, cardiovascular or hematological disease. 8. Any clinical significant illness during the 4 weeks prior to day 1 of this study. 9. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 10. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 11. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 12. HIV and Australian Antigen positive subjects. 13. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.

Design outcomes

Primary

Measure	Time frame
A comparative evaluation of efficacy of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.Timepoint: Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.	—

Secondary

Measure	Time frame
A comparative evaluation of safety & tolerability of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.Timepoint: Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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