AN EXPERIMENTAL DERMAL SAFETY STUDY OF SCHEDULE E (1) DRUG - VISHTINDUKA AND THE ROLE OF ITS TAILA & VATARI GUGGULU IN GRIDHRASI
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3 Toda
研究概览
简要总结
Ayurveda,an ancient science of life, focuses on maintaining balance for health andlongevity. It divides health principles into eight branches, one of which is AgadTantra, dealing with poisons and their treatment. Acharya Charak emphasizedthat poisons, when properly prepared, can become medicines, and conversely,even beneficial medicines can become toxic if used incorrectly. A key part ofAyurveda is understanding Tridosha—the balance of Vata, Pitta, andKapha. When these energies are in equilibrium, health prevails; imbalances leadto diseases.
Onesuch disease is Gridhrasi, similar to sciatica in modern medicine,characterized by pain, stiffness, and restricted leg movement. It arises fromimbalances in Vata, and in some cases, also Kapha. Sciatica is a commoncondition, caused by issues like poor posture, prolonged sitting, and obesity.It affects many individuals, especially those aged 30-50, and often leads topain, disability, and discomfort.
InAyurveda, treatments such as Vishtinduka Taila (derived from Strychnosnux-vomica, a poisonous plant) and Vatari Guggulu (a herbal remedy)are used for conditions like Gridhrasi. These treatments have properties likepain relief, anti-inflammatory, and nerve tonic effects. However, the toxicpotential of these treatments, especially from the use of Vishtinduka, requirescareful evaluation. Toxicity studies in animals are essential to ensure theirsafety for human use.
Thisstudy aims to evaluate the safety of Vishtinduka Taila through dermal exposurein rats and its clinical effectiveness in treating Gridhrasi. Additionally,Vatari Guggulu’s non-toxic profile has already been established. The ultimategoal is to find an effective, safe treatment for sciatica, using traditionalAyurvedic remedies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patient between the age of 18-60 years randomly included in study 2 Sex – both male and female 3 Duration of illness – upto 1 year 4 Tenderness of the Sciatic Nerve course 5 Severe pain on squatting 6 Radiating pain, starting from the gluteal region towards the foot 7 Sensory change 8 Non-involvement of Urinary Bladder and Rectum 9 Positive straight leg raising sign.
排除标准
- •1 Age below 20 years and above 70 years 2 Duration of disease more than 1 years 3 Monoplegia 4 Paraplegia 5 Hip joint arthritis 6 TB Spine/Hip 7 Pelvic pathology 8 Traumatic lesion in lumbo – sacral region.
结局指标
主要结局
3 Toda
时间窗: 30 Days
Subjective parameter
时间窗: 30 Days
1 Stambha
时间窗: 30 Days
2 Ruka
时间窗: 30 Days
11 Mukhapraseka
时间窗: 30 Days
OBJECTIVE PARAMETERS –
时间窗: 30 Days
3 Bowstring’s test
时间窗: 30 Days
4 Sitting time
时间窗: 30 Days
4 Muhurmuhu spandanam
时间窗: 30 Days
7 Tandra
时间窗: 30 Days
5 Sakthikshepana nigrahat
时间窗: 30 Days
8 Gaurava
时间窗: 30 Days
13 Staimitya
时间窗: 30 Days
6 Dehasya pravakrata
时间窗: 30 Days
9 Aruchi
时间窗: 30 Days
12 Bhaktadwesh
时间窗: 30 Days
1 Lasegue’s test
时间窗: 30 Days
2 Bragard’s test
时间窗: 30 Days
5 Standing time
时间窗: 30 Days
6 Walking distance
时间窗: 30 Days
10 Vahnimardavam (Agnimandhya)
时间窗: 30 Days
次要结局
- Effectiveness of Vishatinduka Taila & Vatari Guggulu in reducing pain associated with sciatica. Improvements in patient’s quality of life due to reduced pain & increased mobility would be an important outcome(30 Days)
