临床试验/CTRI/2023/07/055200

CTRI/2023/07/055200尚未招募2 期

A Clinical Study to evaluate the efficacy of ChandanBalaLakshadiTaila Guda Varti After lateral Internal Sphincterotomy in GudaParikartika ( Fissure - in- Ano)

Post Graduate Institute of Ayurved Jodhpur1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2023年7月24日最近更新: 2023年12月7日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 30
试验地点: 1
主要终点: To know the efficacy of Chandalbalalakshadi taila guda varti for post operative pain in guda

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Ayurveda is the science of life which deals with the mental and physical health of a person. Aim of ayurvedais not only to cure disease but also to keep and maintain one’s health. In ancient time and today also ayurveda is followed in every family as home remedy as ritual, in diet form etc.But in the modern era, everyone is busy in their career and has a hurry-buried lifestyle.All became career & money conscious but ignored health. Other than this, everyone is attracted to luxurious life and has competition with others life standards. So, we adopted modernization, fast food, outdoor foods, irregular routine of sleep and diet, which directly indirectly increases the stress level and disturbs sleep. And we all know that our sleep is directly related to our stomach/digestion. All these factors disturb this digestion cycle and lead to constipation or diarrhoea, which further leads to the anorectal and digestion related problems. Fissure is the most common anorectal disease and the common problem associated with this digestive cycle.The description of this condition is described in the ancient treatises as a complication of Virechanaor Basti therapies which goes by the name of "GudaParikartika". Acharya Sushrutadescribed the symptoms of the fissure as cutting or burning pain in anus, penis, umbilical region and neck of urinary bladder with cessation of flatus.

According to modern science fissure in ano is the longitudinal or oval shaped tear wound in the anal canal, below the dentate line extending to anal verge. It may be acute or chronic symptoms include cutting pain, bleeding with defecation and spasticity of anal sphincters.It may be present with a sentinel tag.The most common site for males and females is the posterior midline, greater than 75% occur in this location. Approximately 25% of fissures are in the anterior location and these are more common in women. Less than 1% of all fissures are located off the midline position and these are considered atypical fissures. Fissure may be due to associated with Crohn’s disease, ulcerative colitis, anal cancer, tuberculosis, HIV, syphilis.

MATERIAL AND METHOD:SOURCE OF DATA:Patients with classical sign and symptoms ofGudaParikartika will be selected and registered from OPD and IPD of University College of Ayurveda Hospital, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur; irrespective of age, sex, religion, occupation etc., full filing the criteria of selection and eligible for the study. Patients may be hospitalized as per the requirement and condition of the patient.SAMPLE SIZE:30 patients suffering from GudaParikartika will be selected based on simple random sampling.INFORMED CONSENT:Written informed consent will be taken from each patient before starting the study.

SELECTION OF PATIENTS:

INCLUSION CRITERIA:

â— Patient who will give written consent.

â— Patient should be in 10 to 80 age group.

â— Patient with classical signs & symptoms of GudaParikartika.

EXCLUSION CRITERIA:

â— Patient suffering from AIDS and Hepatitis B.

â— Patient related with any malignancy of Anorectal Region.

â— Patient suffering from uncontrolled diabetes and Tuberculosis.

WITHDRAWAL CRITERIA:

â— Patients which may be found hypersensitive with the selected management will be discarded from the study even after registration.

â— If any serious condition or adverse effect appears during the treatment which requires urgent treatment.

â— If a patient wants to withdraw oneself from the clinical study.INVESTIGATION:

â— CBCï‚· ESRï‚· Blood sugarï‚· BTï‚· CTï‚· Biopsy (as per need)ï‚· HIVâ— HbsAgâ— VDRLâ— PERRECTAL EXAM.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Open Label

入排标准

年龄范围: 10.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•1 Patient who will give written consent.
•2 Patient should be in 10 to 80 age group.
•3 Patient with classical signs & symptoms of GudaParikartika.

排除标准

•â— Patient suffering from AIDS and Hepatitis B.
•â— Patient related with any malignancy of Anorectal Region.
•â— Patient suffering from uncontrolled diabetes and Tuberculosis.

结局指标

主要结局

To know the efficacy of Chandalbalalakshadi taila guda varti for post operative pain in guda

时间窗: 4 weeks

parikartika.

时间窗: 4 weeks

次要结局

To know the efficacy of guda varti of chandanbalalakshadi taila for management of anal(pain after lateral internal sphincterotomy.)

研究者

发起方

Post Graduate Institute of Ayurved Jodhpur

申办方类型

Government funding agency

研究点 (1)

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