An open clinical trial to evaluate the effectiveness of Rasaganthi Mezhugu (Internal) and Powthira Kalimbu (External) in the management of Powthiram (fistula-in-ano) among patients attending Ayothidoss Pandithar Hospital,National Institute of Siddha.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good
研究概览
简要总结
BACKGROUND
Siddha system is one of the ancient systems of medicine, which originated from south India. According to Siddha medicine, diseases were classified into 4448 types based on Mukkutram (Vadham, Pitham, Kabam). Siddha system has a vast Internal and External medicine which cure the diseases. Most of the medicines are aimed at maintaining and balancing three humours (Vadham, Pitham, Kabam). In Yugi Vaithiya Sinthamani, yugi classified the Powthiram disease into 8 types. These are Asana powthiram , Kodi powthiram, Pakka powthiram, Moola powthiram, Kiranthi powthiram, Mega powthiram ,Asana kandamalai powthiram, Sarakandamalai powthiaram. Siddha system of medicine treats the disease in more cost effective and palatable way, when compared with modern medicine. The formulation selected for this dissertation study is Rasaganthi mezhugu (internal),which is described in Pulippani-500 and Powthira Kalimbu Powthiram is characterized as a sinus present inside or outside anus or urethra .The risk factors of powthiram in siddha literatures are, prolonged sitting, consuming spicy foods, horse mount, elephant climb, foods which cause piles. The common symptoms are redness, itching, and pain around the anus region, bloody or pus discharge from the tract .Fistula in-ano is one of the most common anorectal diseases. It is an epithelial lined tract connecting the anal canal to the perianal skin. Anal fistulas can have many causes but are most commonly the result of an anorectal abscess. According to Park’s classification it classified into 4 types (Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric). The symptoms are recurrent anal abscess, pain and swelling around anal region, bloody or foul- smell drainage (pus) from an opening around the anus, pain with bowel movement. The prevalence is greater in men than women, with a rate of 12.3 cases per 1,00,000 and 5.6 cases per 1,00,000 respectively. The average age at diagnosis is 38 years, with most occurring between 20 to 40 years of age .Siddha system of medicine treats the disease in more cost effective and palatable way, when compared with modern medicine. The formulation selected for this dissertation study is Rasaganthi mezhugu (internal),which is described in Pulippani-500 and Powthira Kalimbu (external) which is described in Athmarakchamirtham ennum vaithiya saara sangiragam for Powthiram (fistula- in- ano).So, I have chosen this medicine for management of Powthiram. Kaarathiri is the best procedure for treatment of chronic ulcers, abscess and fistula in ano. Kaarathiri will be prepared by applying kalimbu to sterilised gauze.
OBJECTIVES
I. Primary objectives To evaluate the improvement of symptoms like pain, pus discharge, burning sensation, itching, induration , tenderness around the anus will be assessed by Perianal Disease Activity Index (PDAI)
II. Secondary objective To measure the unit cutting time accessed by, Unit cutting time = total number of days taken for cut through / Initial length of track in cm = ------days/cm
METHODOLOGY
A total of 20 diagnosed patients of Powthiram (fistula in ano) within the age limit of 20-60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Patients with Tuberculosis (Genito urinary tract),Hepatitis B &C, Hemophilia and bleeding disorders, Pregnancy & Lactation, Uncontrolled diabetes, K/H/O Coronary Heart Diseases and other cardiac ailments, HIV, Syphilis, K/H/O Crohn’s disease, High anal fistula and complicated fistula, Rectal prolapse, K/H/O Rectal Carcinoma, K/H/O Ulcerative Colitis will be excluded
OUTCOME OF THE STUDY
Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good outcome of PDAI score becoming zero, [Time points: baseline, interim (Day- 48), and post treatment (Day 96)]
To measure the unit cutting time assessed by Unit cutting time = total no of days taken for cut through / initial length of the tract in cms = -----days / cm [Time points: baseline, interim (Day- 48), and post-treatment (Day 96)]
RESULTS AND DISCUSSION : The result will be statistically analysed and reported.
KEYWORDS: Rasaganthi mezhugu, Powthiram, Fistula in ano, Powthira kalimbu, Kaarathiri
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1.Pus, blood and watery discharge from perianal and anal region.
- •2.Fistula tract – ≤5 cm 3.patient who have low anal fistula.
- •4.Patient who are willing to undergo kaarathiri therapy.
- •5.Willing to give specimen of blood for investigation whenever required.
- •6.Willing to attend OPD or admission in IPD.
- •7.Willing to take photograph before and after treatment 8.Patient already presenting with MRI fistulogram ( Recent one month ) or willing to get the MRI from recognized laboratory (based on St James University Hospital MRI classification for fistula ).
排除标准
- •1.Tuberculosis (Genito urinary tract).
- •2.Hepatitis B & C.
- •4.Pregnancy & Lactation.
- •5.Uncontrolled diabetes.
- •6.K/H/O Coronary Heart Diseases and other cardiac ailments.
- •7.HIV, Syphilis.
- •8.K/H/O Crohn’s disease.
- •9.High anal fistula and complicated fistula.
- •Rectal prolapse.
- •10.K/H/O Rectal carcinoma.
- •11.K/H/O Ulcerative colitis.
结局指标
主要结局
Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good
时间窗: 96 days
outcome of PDAI score becoming zero
时间窗: 96 days
次要结局
- To measure the unit cutting time by using unit cutting time formula(90 days or till the tract heals whichever comes early)
研究者
Dr V Bharathi
National Institute of Siddha