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临床试验/CTRI/2025/04/084024
CTRI/2025/04/084024尚未招募不适用

RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KADALI KSHARSUTRA ALONG WITH GUGGULU PANCHPAL CHURN IN THE MANAGEMENT OF BHAGANDAR W.S.R. TO FISTULA IN ANO

Matoshri Asarbai Darade Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
the Parametres will be noted down before and after treatment.The patient will be diagnosed based on symptoms of parikartika. Explained in ayurvedic And modern texts.

研究概览

简要总结

Present trend in the treatment of fistula in ano in modern medicine is the wide excision of the tract along with the adjacent tissues and wound is allowed to heal, many other surgical procedures example Fistulotomy ,Fistulectomy ,Seton techniques , Flap procedure ,LIFT procedure ,LASER , Endoscopic ablation , Fibrin glue , Bioprosthetic plug  were tried out but none could be adopted as a perfect and curative technique by most of the surgeons, usually inspite of best efforts on the part of the surgeon “the patient after some time again reports pus discharge from the same scar” the frequency of the recurrence is very high and anal continence can also be found in patients .

In spite of much advances in modern medical and surgical science, it is reported that it is not possible to prevent chances of post operative complications like its recurrence rate, high risk of impared continence and nonhealing of the wound after surgical treatment. In additions to this there will be severe post operative pain which persist for many days morever surgical treatment requires hospitalization, regular dressing and post op care for longer duration, to overcome such problems, surgical field is planning for some alternative technique to treat these cases with minimal operative complications, recurrence and failure.For proper healing of wound drug should have two properties as follows:

1]  Vrana Shodhan: for cleaning of the wound

2]  Vrana Ropan: for healing of the wound

It is important to find simple composition which have both vrana shodhan and vrana ropan, Vednahar  properties.

Ayurvedic line of treatment for bhagandara includes medical, para surgical and surgical management. Parasurgical management includes ksharakarma, agnikarma and varti  ksharsutratreatment in bhagandara is chemical fistulectomy rather than surgical fistulectomy. In sushrut Samhita ksharsutra procedure has been described as the best remedy for the disease of nadivrana. there are many ksharsutra which can be used in bhagandar eg guggul coated ksharsutra ,snuhikshir ksharsutra etc. Sushruta in Kshar Paka Vidhi Adhyaya has mentioned 23 drugs from which Kshar can be prepared.Among which Kadali is one of the drug. Kadali has Madhur Rasa, Guru and Snigdha guna , Sheeta Veerya , Madhur Vipaka and Pitta Vatahar properties. It is easily Available . Cost Effective.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Patient with all Classical sign and symptoms of Fistula In Ano.
  • Patient with age group 18 years to 60 years.
  • Patient suffering from fistula in ano specially of low level with simple and complex fistulae will be taken.
  • Patient with HB more than 8 gm % 5) Patient will be selected irrespective of Gender, Religion, Socio-economic status, length of tract , Severity of Disease and Chronicity.

排除标准

  • Pregnancy 2) Patient with HB less than 8 gm % 3) Multiple fistulae in ano , High Anal fistula.
  • Systemic diseases like Extrapulmonary Tuberculosis, Malignancy, Ulcerative colitis, HIV, HBsAG, VDRL positive patient.
  • Patient suffering from uncontrolled DM.
  • Fistula developing along with Piles with Fissure, Prolapsed Rectum, Crohn’s Disease, Rectal polyp, Perianal abscess, etc.

结局指标

主要结局

the Parametres will be noted down before and after treatment.The patient will be diagnosed based on symptoms of parikartika. Explained in ayurvedic And modern texts.

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

1.Pain

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

2.Healing

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

3.local tenderness

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

4.wound healing

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

5.discharge

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

6.length of track

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

7.unit cutting time

时间窗: 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks

次要结局

未报告次要终点

研究者

发起方
Matoshri Asarbai Darade Ayurved Mahavidyalaya
申办方类型
Other [Research institution and hospital]
责任方
Principal Investigator
主要研究者

Dr Jaydeep Sunil Borse

Matoshri Asarabai Darade Ayurved Mahavidyalaya Tal.Yeola Dist. Nashik

研究点 (1)

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