A Comparative Clinical Study to Evaluate the Efficacy of Topical Application of Panchavalkala Cream versus Povidone Iodine Ointment in the Management of Post-Operative Wound of Parikartika (Chronic 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 Fissure Bed
研究概览
简要总结
REVIEW OF LITERATURE
- Disease Review
a Ayurvedic Review Parikartika is explained under the Vamana and Virechana Vyapada. Nidana, Samprapti, and Lakshana of Parikartika are explained in Sushruta Samhita Chikitsa Sthana Chapter 34 Verse 16. The major texts of Ayurveda, Charaka Samhita and Sushruta Samhita, described Parikartika as complications Vyapat of Basti and Virechana. Nidana, Samprapti, Lakshana, and Chikitsa of Parikartika are mentioned in these texts. Acharya Kashyapa described Parikartika and its types in Garbhini Chikitsa.
b Modern Review Definition, etiology, pathology, signs and symptoms, examination, and treatment of fissure-in-ano will be reviewed.
- Drug Review The detailed description of Panchavalkala cream and Povidone Iodine ointment in post-operative wound management of Parikartika chronic fissure-in-ano will be reviewed critically.
AIMS AND OBJECTIVES OF STUDY
- To review Parikartika and fissure-in-ano in detail
- To evaluate the efficacy of Panchavalkala cream in post-operative wound management of Parikartika
- To evaluate the efficacy of Povidone Iodine ointment in the same condition
- To compare and ascertain the efficacy of both treatments in the post-operative wound management of Parikartika
HYPOTHESIS
a Null Hypothesis H0 There is no statistically significant difference between the efficacy of Panchavalkala cream and Povidone Iodine ointment.
b Alternative Hypothesis H1 There is a statistically significant difference in efficacy.
MATERIAL AND METHODS
7.1 SOURCE OF DATA
A Literary Source Texts of Ayurveda, modern references, and online sources
B Drug Source From SSRAMC Pharmacy Inchal i. Raw material from approved vendors ii. Cream preparation at SSRAMC lab iii. Povidone iodine from authorized pharmacy
C Sample Source Patients diagnosed with chronic fissure-in-ano from OPD and IPD of Shalya Tantra, SSRAMC, Inchal
Grouping
- Type of Study: Interventional
- Design: Two-arm, open-labeled, active controlled, randomized prospective clinical study
- Sampling: Purposive
- Sample Size: 60 patients
- Group A: Panchavalkala cream application for 21 days
- Group B: Povidone Iodine ointment application for 21 days
- Treatment Duration: 21 days
Plan of Study Fissurectomy followed by local application. Diet advice, antibiotics, analgesics, and discharge by third day. Application of ointments for 21 days with sitz bath.
ASSESSMENT CRITERIA
Pain – Oozing – Ulcer – Discharge
ASSESSMENT CRITERIA:
| GRADATION |
PAIN
OOZING OF BLOOD
ULCER IN
ANO
ANY
DISCHARGE
|0
No pain
Nil/ spotless gauze
No ulcer
No discharge
|1
Pain at the time defeacation and subside within 30 minutes
Few drops of blood in gauze 2’’X2’’
Presence of ulcer with indurated margins
Mild discharge and no requirements of pads
|2
Pain at the time defecation and subside more than 30 minutes to 1 hour
Half gauze wetted with blood 2’’X2’’
Presence of ulcer with indurated margins
Changing of pads one a day
|3
Continuous unbearable pain which persist for
More than 1 hour
Total gauze wetted with the blood 2’’X2’’
Presence of ulcer with indurated margins and slough
Changing of pads more than once a day
FOLLOW-UP
Once per week for 4 weeks
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both sexes irrespective of religion, occupation, socio-economic status, etc.
- •Patients who are clinically diagnosed as a case of parikartika and have undergone fissurectomy procedure recently.
- •3.Patients preferably aged between 18-60 years.
- •4.Patients willing to sign informed consent and ready to a bide to study protocol.
排除标准
- •Patients suffering from systemic diseases like Diabetes mellitus, Hypertention, Tuberculosis will be excluded from the study.
- •Patients found associated with HbsAg +ve and HIV +ve will be excluded from the study.
- •Patients of fissure-in-ano associated with other Ano-rectal conditions like Hemorrhoids, Fistula-in-ano, Ca Rectum and also suffering from ulcerative colitis, chron’s disease etc.
- •will also be excluded from the study.
结局指标
主要结局
Healing Fissure Bed
时间窗: 21 Days
Reduction in Bleeding during and Post defecation
时间窗: 21 Days
Tag Removal
时间窗: 21 Days
次要结局
- Reduction in pain(Normalizing Sphincter tone)
研究者
Dr Sambhaji S Garje
Shri Shivayogeeshwar Rural Ayurvedic Medical College