Post-marketing surveillance study of Palsinuron for acute lumbar radicular pain (sciatica): arandomized, double-blind, placebo-controlled, comparative, multi-centric clinical study. - NI

S. G. Phyto Pharma Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Male or female of age between 18-65 years (both inclusive);
•2. Participants with a mild to moderate pain score of 1 to 7 both inclusive on the Numerical Rating Scale at the screening;
•3.Based on clinical judgment of study investigators and or MRI or CT imaging there should be evidence of a pathological disc or foraminal stenosis or both at a level consistent with the patients history and physical examination;
•4. The duration of symptoms for the current episode should be less than 4 weeks, with a maximum duration of up to 12 weeks;
•5. Participants with or without comorbidity. If comorbid the patient should be on stable medication for the last three months, with no worsening of symptoms and or need for hospitalization; or can be enrolled into the study at per discretion of the investigator.

•1. Previous transforaminal epidural or oral steroids at any level in the last 6 months;
•2. Any lumbar surgery at same level, or above or below the level at any time;
•3. Direct indication for neurosurgery;
•4. Any serious medical or psychiatric condition that may interfere with participation or outcome assessment such as need for uninterrupted anticoagulation, spinal fracture, active infection or metastatic disease suspected, active cancer, previous or current psychiatric history of bipolar disease;
•5. Poorly controlled diabetes HbA1c more than or equal to 8%, uncontrolled hypertension systolic blood pressure
•greater than 180 or diastolic blood pressure greater than 110, active peptic ulcer disease;
•6. History or presence of substance abuse;
•7. Pregnancy, or lactation/breastfeeding;
•8. Participants with pre-existing hypersensitivity to any ingredients of the investigational products; (Mahavatvidhwans, Sameerpannag, Ekangveer Ras, Sootshekhar, Khurasani Owa Powder, Lajari Panchang Powder)
•9. Participants currently using or have taken gabapentin within last 3 months;
•10. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes

发起方

S. G. Phyto Pharma Pvt. Ltd