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临床试验/CTRI/2025/04/085932
CTRI/2025/04/085932尚未招募Phase 3 4

AN EXPERIMENTAL DERMAL SAFETY STUDY OF SCHEDULE E (1) DRUG - VISHTINDUKA AND THE ROLE OF ITS TAILA & VATARI GUGGULU IN GRIDHRASI

Department of Agadtantra Evum Vidhi Ayurved Shri NPA Govt Ayurvedic College GE road Raipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月17日最近更新:

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)

研究者

发起方
Department of Agadtantra Evum Vidhi Ayurved Shri NPA Govt Ayurvedic College GE road Raipur
申办方类型
Government medical college

研究点 (1)

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