Comparative Pharmacognostical and Clinical Study of Parijata (Nyctanthes arbor-tristis Linn) and Nirgundi (Vitex negundo Linn) as Vedanahara in Gridhrasi with Special Reference to Sciatica.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary outcome of study is:
Study Overview
Brief Summary
"Comparative Pharmacognostical and Clinical Study of Parijata (Nyctanthes arbor-tristis Linn) and Nirgundi (Vitex negundo Linn) as Vedanahara in Gridhrasi W.S.R to Sciatica", aims to compare the efficacy and safety of two herbal treatments—Parijata (Nyctanthes arbor-tristis) and Nirgundi (Vitex negundo)—in the management of Gridhrasi (Sciatica), which is a common cause of lower back and leg pain.
Study Objectives:
Pharmacognostical Comparison: To analyze the pharmacological properties, active constituents, and quality of the two herbs.
Clinical Comparison: To evaluate the therapeutic effects of Parijata and Nirgundi in treating sciatica symptoms, including pain relief, functional improvement, and quality of life.
Study Design:
A randomized, parallel group, active control trial where participants will be assigned to receive either Parijata, Nirgundi, or a standard treatment.
Primary Outcomes:
Pain reduction using tools like the Visual Analog Scale (VAS)
Functional improvement through disability assessments
Secondary Outcomes:
Reduction in inflammation, assessed by CRP levels.
Improvement in range of motion by SLR TEST
Tracking of adverse effects and patient satisfaction.
Conclusion:
The study will help determine the effectiveness of these two herbal treatments in reducing sciatica symptoms, contributing to the understanding of Ayurvedic therapies in managing Gridhrasi (Sciatica). The findings could provide valuable insights into integrating these herbs as potential treatment options for sciatica in clinical settings.
This study is crucial for advancing knowledge in Ayurvedic pain management and could have significant implications for treating sciatica with natural remedies.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age between 20-60 years, irrespective of gender, caste, religion and socioeconomic status were selected for study Patients suffering with Low back ache radiating to lower limbs Patients presenting with lakshanas of gridhrasi.
Exclusion Criteria
- •Patients suffering with below mentioned conditions will be excluded Uncontrolled Diabetes Mellitus and Hypertension Loss of bowel and bladder control Spondylolisthesis Vertebral Fractures Foot drop Psychiatric disorders Pott’s spine Post spinal surgical cases Severe systemic disorders Malignancy.
Outcomes
Primary Outcomes
The primary outcome of study is:
Time Frame: The time points for the study are as follows: | 1. Baseline Assessment: | Conducted on Day 1 before starting the treatment. | 2. Duration of Treatment: | The treatment will be administered for 45 days. | 3. Patient Reviews: | Patients will be reviewed every 15 days during the treatment period (i.e., on Day 15, Day 30, and Day 45). | 4. Follow-Up: | A follow-up assessment will be conducted 30 days after completing the treatment.
Reduction in pain levels in patients with Gridhrasi (Sciatica).
Time Frame: The time points for the study are as follows: | 1. Baseline Assessment: | Conducted on Day 1 before starting the treatment. | 2. Duration of Treatment: | The treatment will be administered for 45 days. | 3. Patient Reviews: | Patients will be reviewed every 15 days during the treatment period (i.e., on Day 15, Day 30, and Day 45). | 4. Follow-Up: | A follow-up assessment will be conducted 30 days after completing the treatment.
Measured using: Visual Analog Scale (VAS) & other parameters.
Time Frame: The time points for the study are as follows: | 1. Baseline Assessment: | Conducted on Day 1 before starting the treatment. | 2. Duration of Treatment: | The treatment will be administered for 45 days. | 3. Patient Reviews: | Patients will be reviewed every 15 days during the treatment period (i.e., on Day 15, Day 30, and Day 45). | 4. Follow-Up: | A follow-up assessment will be conducted 30 days after completing the treatment.
Secondary Outcomes
- 1) Functional improvement(2) Reduction in inflammation)
Investigators
Dr. Pola Karthikeya
Dr. BRKR Government Ayurvedic College