A Clinical trial to determine the effectiveness of Gowri Chinthamani Chendooram (Internal) and Pachai ennai (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
- Outcome will be assessed by Peri-anal Disease Activity Index(PDAI) and good outcome of PDAI score becoming zero[Timepoints:Baseline and Post treatment (Day 48)]
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 medicines which cure the diseases. Most of the medicines are aimed at maintaining and balancing three humours (Vadham, Pitham, Kabam). In Yugi Vaithiya chinthamani, yugi classified the Powthiram disease into 8 types. 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 fistula tract. According to Park’s classification it is classified into 4 types (Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric). 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.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening, any associated tracts, or any secondary openings without change in incontinence. The simplest anal fistula are treated using fistulotomy with a recurrences and the other morbidities.Complex fistula management poses increased risk of a change in incontinence and the higher chances of recurrences which forced surgeons to search for a better option.Various modalities like cutting seton, Endorectal advancement flap, fibrin glue injection, fistula plug, Ligation of intersphincteric Fistula Tract (LIFT) are being tried to overcome the hardship faced by the patients. 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 Gowri chinthamani chendooram (internal), which is described in Agasthiyar vaithiya kaviyam- 1500 and Pachai ennai (external) which is described in The pharmacopoeia of Siddha research medicines 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.Thiri will be prepared by applying Pachai ennai to sterilised gauze.
OBJECTIVES:
Primary objective:To determine the effectiveness of Gowri chinthamani chendooram (Internal) and Pachai ennai (External) in the management of Powthiram through Perianal Disease Activity Index (PDAI) score.
Secondary objective: To measure the unit cutting time assessed by, Unit cutting time = total number of days taken for cut through / Initial length of track in cms = ------days / cm.
STUDY DESIGN:
This is an interventional study of Non Randomized sampling which will be carried out for 18 months in participants with Fistula-in-Ano reporting to OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha,Chennai-47 with 20 Participants as Sample size.Participants with age from 18 to 60 years of both age and with Fistula-in-ano will be included.
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 and post-treatment (Day 48)]
Outcome will be assessed by unit cutting time, Unit cutting time = total no of days taken for cut through / initial length of the tract in cms = -----days / cm [Time points: baseline and post-treatment (Day 48)].
RESULTS AND DISCUSSION:
The results will be statistically analysed and reported.
KEYWORDS:
Powthiram, Gowri Chinthamani Chendooram, Pachai ennai, Fistula-in-Ano.
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 Day(s) 至 60.00 Day(s)（—）
- 性别
- All
入选标准
- •Participants having the clinical features of the following Pain and swelling in the perianal region Pus or blood discharge from perianal and anal region Skin irritation Perianal abscess Fistula tract length less than 5 cm.
- •According to St James University Hospital Classification of Perianal Fistula,Grade I and Grade II.
- •Participants willing to undergo Kaarathiri therapy.
- •Participants already presenting with MRI Fistulogram or willing to undergo the MRI from recognized laboratory.
排除标准
- •Infectious risk category [Tuberculosis (Genitourinary tract),Hepatitis B & C,AIDS,Syphilis] Hemophilia and bleeding disorders.
- •Pregnancy and lactation.
- •High anal fistula and Complicated fistula.
结局指标
主要结局
Outcome will be assessed by Peri-anal Disease Activity Index(PDAI) and good outcome of PDAI score becoming zero[Timepoints:Baseline and Post treatment (Day 48)]
时间窗: 18 months
次要结局
- Outcome will be assessed by Unit Cutting time,(Unit cutting time=Total no f days taken for cut through/Initial length of the tract in cms=-----days/cms[Baseline and Post treatment (Day48)])