A Comparative Clinical Study to Evaluate the Efficacy of Lajjalu Taila Pichu versus Yashtimadhu Taila Pichu in the Management of Parikartika W.S.R. to Acute Fissure-in-Ano.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Healing of Fissure
研究概览
简要总结
A)TYPE OF STUDY: A comparative clinical Interventional study
B) TREATMENT GROUP:
60 diagnosed patients of Parikartika based on clinical evaluation of lakshanas will be selected and divided into 2 equal groups, namely Group A( Trial group) and Group B (Control Group) of 30 each.
C) DURATION OF TREATMENT:
Group A (Trial group): Number of patients 30
Procedure: Local application of lajjalu taila pichu once daily.
Duration: 10 days
Group B (control group): Number of patients 30
Procedure: Local application of yashtimadhu taila pichu once daily.
Duration: 10 days
Clinical features are recorded before the treatment i.e., on day zero. Changes with the treatment will be observed on 10th day, as per the proforma of the case sheet, prepared for the study
D) SAMPLE SIZE:
60 patients fulfilling the diagnostic and inclusion criteria of either sex will be selected for the study.
E) DIAGNOSTIC CRITERIA: Diagnosis will be made based on clinical evaluation i.e., lakshanas like kartanavat shoola (cutting type of pain), daha (burning sensation), kandu (itching), shonita srava (bleeding).
F) ASSESSMENT CRITERIA: Assessment will be done by giving specific gradation to subjective and objective criteria.
Subjective criteria :
| Gradation |
Pain
P/R bleeding during defecation
Ulcer in ano
|0
no pain
nil
no ulcer
|1
pain at the time of defecation and subside within 30 minutes
streak of blood over the surface of the stool
ulcer with healthy granulation tissue
|2
pain at the time of defecation and subside more than 30 minutes to less than 1 hour
dropwise bleeding during the passage of stool (5-6 drops)
presence of ulcer with indurated margins
|3
continuous unbearable pain at the time of defecation which persist more than 1 hour
moderate bleeding during the passage of stool (20-25 drops)
presence of ulcer with indurated margins and slough
Objective criteria :
a) Assessment of sphincteric spasm.
Assessment of objective criteria will be made before and after treatment on the
basis of gradation.
Sphincteric spasm
0 = Normal (No spasm of anal sphincter)
1 = Mild (Spasm anal sphincter present)
2 = Moderate (Due spasm of anal sphincter)
3 = Severe (Per rectal examination not possible due to severe spasm of
anal sphincter)
b) Size of ulcer ( Fissure bed )
Assessment of objective criteria will be made before and after treatment on the
basis of gradation.
| Gradation |
Size of ulcer
|1
Below 5 mm
|2
5 mm to 10 mm
|3
Above 10 mm
Overall assessment of treatment
| Sr.no |
Result
Assessment
|1
Cured
Relief in pain and discomfort within 10 days and wound healing within 30 days
|2
Moderate improvement
Relief in pain but mild discomfort within 11-20 days and wound healing within 30 days
|3
Mild improvement
Mild relief in pain and discomfort within 21-30 days and wound healing within 30 days
|4
No relief
No relief in pain and discomfort till 30 days
FOLLOW UP :
Patient will be advised for follow up once on 10th day for 30 days. Clinical observations will be recorded systematically.
ADVISE :
Laghu, anabhishyandi aahara. intake of fluids.
Avoid ruksha diet, avoid junk and spicy foods, and beverages.
G). STATISTICAL ANALYSIS :
The data will be collected and statistically analyzed using appropriate tests by consulting a statistician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients irrespective of religion, occupation, socio-economic status.
- •Patients who are clinically diagnosed as a case of parikartika.
- •Patients who are k/c/o Hypertension, Diabetes Mellitus only which are under control limit will also be considered for the study.
排除标准
- •Patients who are aged below 20 years and more than 60 years.
- •Patients of Parikartika secondary to other diseases like rectal carcinoma , ulcerative colitis, crohn’s disease, tuberculosis etc.
- •Patients with uncontrolled hypertension and diabetes.
- •Patients who are diagnosed as HIV +ve, HbsAg +ve will also be excluded from the study.
结局指标
主要结局
Healing of Fissure
时间窗: 10 Days
Reduction in Bleeding during defecation
时间窗: 10 Days
次要结局
- Releavinf spincter spasm(Reduction in pain)
研究者
Dr Dinesh B Varvadiya
Shri Shivayogeeshwar Rural Ayurvedic Medical College