A COMPARATIVE CLINICAL ASSESSMENT OF STANDARDIZED KSHARASOOTRA WITH AND WITHOUT SNUHI KSHARA IN THE MANAGEMENT OF BHAGANDARA W.S.R. FISTULA-IN-ANO
试验速览
- 阶段
- Phase 3 4
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Relief in sign and symptoms of fistula in ano and complete cure
研究概览
简要总结
Bhagandara is one among the eight Mahaagadas described by Maharshi Sushruta. Acharya Sushruta has mentioned that all types of Bhagandara are difficult to treat. In modern medicine, a fistula-in-ano is an abnormal communicating tract between anal canal and peri-anal skin. It is also known for its significant risk of recurrence (0.7–26.5%) and high risk of impaired continence (5–40%) in modern surgery. Basing upon the clinical manifestations, fistula in ano can be correlated with Bhagandara clinical entity described by *Acharya Sushruta.*Ksharsootra is a very well -known alternative therapy for the management of Fistula-in-ano.In present study, Snuhi Kshara isselected on the basis of its Tikshna property to evaluate their clinical efficacy in fistula-in-ano and classical Snuhi Ksheera based Ksharsootra to evaluate its clinical efficacy in the management of fistula in ano. The Indian Council of Medical Research (ICMR) has validated it and WHO has accepted the effectiveness of this an Ayurvedic treatment modality in treating fistula in ano. So, Standardization of Kshara and Ksharsootra are prime need before their clinical application. This study has been planned for standardization of Snuhi Kshara, Ksharsootra and their comparative clinical assessment in the management of Bhagandara (fistula-in-ano).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1 All types of low anal fistula in ano (Vataja, Pittaja, Kaphaja, Vata-Pittaja, Vata-Kaphaja and Arsho-Bhagandara (Kapha-Pittaja) 2Fistula in ano with controlled TB, DM, Hypertension.
排除标准
- •1Sannipaataja and Agantuja Bhagandara 2Fistula other than fistula-in-ano.
- •3High anal fistula in ano.
- •4Fistula associated with uncontrolled TB, DM, Hypertension or Osteomyelitis, Venereal Disease, Pregnancy, Chronic or acute ulcerative colitis, Crohn’s disease.
结局指标
主要结局
Relief in sign and symptoms of fistula in ano and complete cure
时间窗: 30 to 60 days
次要结局
- Optimum working device from two types of ksharasutra in the management of fistula in ano by Ayurved(30 to 60 days)
