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临床试验/CTRI/2024/12/078363
CTRI/2024/12/078363招募中2/3 期

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.

Dr BRKR Government Ayurvedic College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
The primary outcome of study is:

研究概览

简要总结

"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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The primary outcome of study is:

时间窗: 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).

时间窗: 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.

时间窗: 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.

次要结局

  • 1) Functional improvement(2) Reduction in inflammation)

研究者

发起方
Dr BRKR Government Ayurvedic College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Pola Karthikeya

Dr. BRKR Government Ayurvedic College

研究点 (1)

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