A COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF ASHWATHA OINTMENT AND ASHWATHA TAIL ON PARIKARTIKA WITH SPECIAL REFERENCE TO ACUTE FISSURE IN ANO
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Reduce The Sign And Symptoms Of Acute Fissure in Ano
研究概览
简要总结
OBJECTIVES Primary
• To determine the effect of Ashwatha Ointment on parikartika (Acute Fissue in Ano)
• To determine the effect of Ashwatha Tail in the management on parikartika (Acute
Fissue in Ano)
• To compare effect of Ashwatha Ointment and Ashwatha Tail on parikartika (Acute
fissure in ano)
Secondary
• To study Formulation Procedure of Ashwatha Ointment and Ashwatha Tail as per standard protocol.
PARTICIPANTS:-41 number of patients of each group having age between 18yrs to 70yrs suffering with sign and symptoms of Acute Fissure in Ano and meeting inclusion and exclusion criteria will be randomised And selected for study from OPD AND IPD department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik.
INTERVENTIONS-
41 Patient In group A selected for Ashwatha ointment application
41 Patient in group B selected for Ashwatha oil application
Primary Outcome :
Reduce the sign and symptoms of Acute Fissure in Ano.
Secondary outcome:
Provide long term relief and reduce recurrence.
Treatment Duration : 15 Days
Follow Up :5th , 10th , 15th Days
Data Analysis : Data will be analysed using appropriate statistical methods to compare the
effectiveness of the both intervension group.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with
informed consent from participents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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 Clinically diagnosed cases of Parikartika (Acute fissure in ano) will be taken for the study.
- •2 Patients irrespective of gender, religion, occupation & economic status.
- •3 Patients between the age group of 18 to 70 years.
- •4 Patients which agreed for treatment with informed consent.
排除标准
- •1 Age less than 18 years and more than 70 years.
- •2 Patients having Parikartika (Acute Fissure-in-ano) secondary to Ulcerative colitis,Syphilis, Crohn ‘s disease, Tuberculosis and Ca of rectum and anal canal.
- •3 Patients with infectious diseases like HIV/ HbsAg / HCV.
- •4 Patient with uncontrolled Diabetes and Hypertension.
- •5 Patients associated with conditions like Hemorrhoids (Arsha), Fistula-in-ano (Bhagandar).
- •6 Patients with Perianal abscess, rectal prolapsed and severe local sepsis.
- •7 COPD/ Severe Bronchial Asthma.
- •8 Any previous anal surgery.
- •9 Not willing to give consent.
结局指标
主要结局
Reduce The Sign And Symptoms Of Acute Fissure in Ano
时间窗: 15 days
次要结局
- To provide long term relief and reduce recurrence of Fissure in Ano(10 days)