Clinical study to treat patients with peripheral neuropathic pain with coexistent Vitamin B12 deficiency with the help of FDC of Gabapentin SR plus Methylcobalamin plus Nortriptyline film-coated bilayered tablets.
- Conditions
- Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
- Registration Number
- CTRI/2024/01/062148
- Lead Sponsor
- Ravenbhel Healthcare Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
The study aims to evaluate patients aged 18-75 with neuropathic pain, Gabapentin and Methylcobalamin treatment, decreased Vitamin B12 levels, and non-specific symptoms like allodynia, burning, shooting, or hyperalgesia.
Participants must sign an informed consent document and adhere to all protocol procedures.
Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
Patients using gabapentin for any other neurologic disorders unrelated to peripheral neuropathic pain.
Patient taking any other medication for the treatment of peripheral neuropathic pain last two weeks.
Patients with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) >11%.
Patients with abnormal eGFR ( <60 mL/min/1.73 m2).
Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
Ongoing administration of Monoamine Oxidase (MAO) inhibitors.
Patients with medical history of Oncological Conditions.
Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (e.g. MI), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension.
Patients with known cases of HIV, Hepatitis B & C.
Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.
Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
Pregnant woman or lactating mother.
Patients participated in any type of clinical study within the last 3 months of the screening date.
Patients with known alcohol abuse within last one year and dependency on narcotics, opioids, or any other addictive substances.
Patients with an inability to comply with the protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Pain Intensity Numerical Rating Scale (PI-NRS) from baseline to end of the study (8 weeks).Timepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method Change in the Vitamin B12 levels from baseline to end of the study (8 weeks). <br/ ><br>Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of the study (8 weeks).Timepoint: 8 weeks