跳至主要内容
临床试验/CTRI/2025/08/093445
CTRI/2025/08/093445尚未招募2/3 期

A comparative clinical study to evaluate the effect of arka based apamarga kshara sutra and Z Plasty in shalyaja nadivrana with special reference to pilonidal sinus

Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To see the difference in effectiveness, feasibility, recovery and chances of recurrence (if any) in two treatment groups Viz- Arka based Apamarga kshara sutra and Z-plasty in Shalyaja Nadivrana with special reference to Pilonidal sinus.

研究概览

简要总结

Nadivrana is a disease of concern today which is defined as one which is having a track like a reed, the nature of which remains unhealed with the characteristics of discharge of pus caused due to the improper treatment of Pakwa Shopha. Nowadays, amongst all types of Nadivrana, the prevalence of Shalyaja Nadivrana which has baala (hair) embedded is higher in clinical practice. Lakshanas include ruja and puyasrava. Treatment includes- Upanaha, Chedana, Aaharana of Shalya, Ksharasutra, Varti, and Pratisaraniya Kshara. Shalyaja Nadivrana can be compared to the Pilonidal Sinus in contemporary sciences.

A pilonidal sinus is a cavity containing hair that is found typically above the level of the first piece of coccyx. A tuft of hair projects from its mouth. Amongst various sites like Webs of fingers, Axilla and Natal cleft, the commonest site is at the natal cleft. The Subject complains of blood stained foul discharge from the sinus at natal cleft. Pain and Tenderness are often associated with due to recurrent infection. The incidence of the disease at natal cleft is 26 per 1,00,000 population in India. The male is to female ratio is 3-4:19. Treatment options include- Excision of the Sinus, Open Surgery, Marsupialization, Z-plasty and Laser Ablation.

Amongst Shastra and Anushastra, Kshara is pradhana. Also, Kshara has Chedana, Bhedana, and Lekhana in addition to Shodhana, Ropana and Stambhanadi properties. Kshara sutra which imbibes all these properties is feasible, effective and can be performed on OPD basis. Z-Plasty is an effective treatment in contemporary science.

The treatment protocol of Nadivarna includes Kshara sutra. Apamarga kshara is mentioned in Ksharapakavidhi adhyayam. Arka ksheera can be used as a binding agent in the preparation of Kshara Sutra.

Shalyaja Nadivrana is a disorder that causes discomfort, pain and hampers day to day activities of the Subject. The suffering is due to the delayed approach of the Subject to the doctor. Hence, treatment of this is of utmost importance. As Shalyaja Nadivrana at natal cleft is one of the least explored area at par with contemporary science, so this study has been taken up to analyse the effect of Arka based Apamarga kshara sutra and Z-plasty in Shalyaja Nadivrana with special reference to Pilonidal sinus.

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)(—)
性别
All

入选标准

  • Subjects presenting with signs and symptoms of Shalyaja Nadivrana (Pilonidal Sinus) such as Pain, Pus discharge and presence of tract in the natal left which will be confirmed after probing.
  • Subjects having Shalyaja Nadivrana in the natal cleft (Pilonidal Sinus) aged between 18-60 years, irrespective of gender, caste and religion will be selected.

排除标准

  • Subjects having Shalyaja Nadivrana in the natal cleft (Pilonidal Sinus) diagnosed with any systemic disease interfering with the course of treatment like Uncontrolled Diabetes mellitus, Osteo myelitis, Tuberculosis, Immune compromised conditions, malignancy and Pregnancy will be excluded.

结局指标

主要结局

To see the difference in effectiveness, feasibility, recovery and chances of recurrence (if any) in two treatment groups Viz- Arka based Apamarga kshara sutra and Z-plasty in Shalyaja Nadivrana with special reference to Pilonidal sinus.

时间窗: 4 weeks and 6 weeks

次要结局

未报告次要终点

研究者

发起方
Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru
申办方类型
Other [Private ayurveda medical college hospital and research centre]
责任方
Principal Investigator
主要研究者

Dr Manoj D C

Sri Kalabyraveshwaraswamy ayurvedic medical college hospital and research centre bengaluru

研究点 (1)

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