Health Condition 1: M544- Lumbago with sciatica
Conditions
Interventions
None listed
Sponsors
S. G. Phyto Pharma Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in Numerical Rating Scale NRS score for leg pain. 2. Changes in Oswestry Disability Index ODI scoreTimepoint: At Screening, Day 7, and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in quality of life using Euro QoL 5D score 2. Changes in vital signs 3. Changes in TNF-alpha, In 5 patients from each group.Timepoint: At Screening, Day 7, and Day 14 | — |
Countries
India
Contacts
Public ContactDr Shreehari Taklikar
Mprex Healthcare Pvt Ltd
Outcome results
None listed