Efficacy of Katupiladi Ghrita Pichu and Jatyadi Ghrita Pichu in themanagement of Parikartika (Acute fissure- in- ano) An open labelledrandomized controlled clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of Parikartika that is absence of bleeding per ano , absence of linear ulcer of true skin of anal canal which comes under subjective criteria and reduction in pain in ano which will be assessed by VAS Scale and reduction in spasm in ano which comes under subjective criteria .
研究概览
简要总结
The health of an individual dependssolely on his diet & life style.Diet plays very important role.Parikartika(Acute fissure in ano)which is evident by references.
Fissure-in-ano is a most troubling and painfulcondition. They can be acute or chronic and often cause symptoms and suffering out of proportion to the size andsize of lesion.
Fissure are more commonly encountered in younger andmiddle aged adults, but also occur in children and elderly. Both sexes are affected equally.
The Vast majority of Fissure is a linear ulceration fromdentate line to anal verge. Majority of fissuresoccur as a single tear in midline. Mostly 75% to 90% occur in the posteriormidline. Acute anal fissures appearas a longitudinal or elliptical tear in mucosal lining of anal canal. When symptomsare present for morethan 8 to 12 weeks, the fissureoften develops chronicity.
In Ayurveda, thevitiated Apanavayu can be consideredas a chief causative factor for the manifestation of Parikartika. In Ayurveda, the detailed description of Parikartika has been found in scatteredmanner in Samhita as a complication of various diseases like Vatika Jwara(*Ch.Chi.*3/186), Vatika Pakva Atisara(Ch.Chi.19/5), Sahaja Arsha (Ch.Chi.14/8), Kaphaja Arsha(Ch.Chi.14/17),Arsha Purvarupa (Su.Ni.2/8), Udavarta (Ch.Chi.26/5-6) in Garbhani (Ks. Kh. 10/10), unlawful administrationof purgative or enema (Ch.Si. 6/62). Later on especiallyKashyapa and Sharangdhara have described the details regarding the Doshikatypes. Kashyapa has mentioned three types of Parikartika according to predominance of the Doshaand their treatmentaccordingly. As per the classical description of signs and symptoms, thedisease Parikartika iscorrelated with fissure in ano in modern parlance.
Significance: Acute fissureis a condition that affectsa great majorityof the population and occursat any age irrespective of gender having prevalence rate approximately 30% to 40% of total ano- rectal diseases.This diseaseof anus demand urgent relieffrom burning pain.Dueto severe anal pain most of patientdemand conservative management at OPDlevel
Aims and objectives:
1.Toevaluate and compare the clinical effect of KatupiladiGhrita Pichu and Jatyadi Ghrita Pichuin the management of Parikartika(Acute fissure in ano).
2.To compare Katupiladi Ghrita and Jatyadi Ghrita for theirpharmacognostical and phytochemical properties.
Materials and Methods:
Patients of parikartika(Acutefissure in ano) having signs and symptomsof acute fissure in ano that is burning pain in ano,bleeding per ano(streak ofblood with stool),increased spasm tone,linear ulcer in anal canal will beselected from OPD/IPD of ShalyaTantra, I.T.R.A ,Jamnagar,irrespective of gender,occupation,caste and religion etc.
Grouping of patients:The patients will be dividedrandomly into A and B groups by computer generated Randomization method viz. (Minimum 15 patients in eachgroup).
Group-A:Local application of *KatupiladiGhrita(*Pichu) in fissure bed (Parikartika) ?(Acute fissure in ano)twice a day after sitz bath for 2 weeks.
Group-B (Standard control): Local application of Jatyadi Ghrita Pichu in fissurebed, twice a day after sitz bath for 2 weeks.
Results and Discussion:Data generated during the above study will be presentin a Systemic manner and shall be analyzedstatically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.
**Follow****up:**After completion of therapy,follow up will be done after 15 daysof 2 sittings to assessthe status of patient,where patient will be asked to report.
Adverse effects: Thisdrug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of Parikartika Acute fissure-in-ano having duration less than upto 4weeks.
- •2.Age group between 20-50years of either gender.
- •3.Controlled Hypertension and Diabetes mellitus.
排除标准
- •1.Fissure-in-ano having duration- more than 4 weeks or as developed sentinel tag.
- •2.Age group less than 20 years and greater than 50 years.
- •3.Patient suffering from malignancy.
- •4.Patient suffering from HIV, VDRL, Hepatitis-B, T.B, HCV, Paralysis,Parkinsonism, Known case of cardiac diseases (H/O- MI, IHD) or secondary causes.
- •5.Fissure-in-ano associated with fistula and fissure bed infections.
- •6.Multiple fissure in ano.
- •7.Ulcerative colitis, Crohn’s disease,STD .
结局指标
主要结局
Relief in signs and symptoms of Parikartika that is absence of bleeding per ano , absence of linear ulcer of true skin of anal canal which comes under subjective criteria and reduction in pain in ano which will be assessed by VAS Scale and reduction in spasm in ano which comes under subjective criteria .
时间窗: Relief in signs and symptoms of parikartika after 2 weeks of completion of treatment and follow up on every 15 days for 1 month.
次要结局
- Assessement of subjective criteria that is absence of bleeding per ano , absence of linear ulcer of true skin of anal canal and reduction in pain in ano which will be assessed by VAS Scale, reduction in spasm in ano which comes under subjective criteria .(Relief in signs and symptoms of parikartika after 2 weeks of completion of treatment and follow up on every 15 days for 1 month.)