A Comparative Clinical Study on Efficacy of Snuhyadi Varti and Apamarga Kshara Sutra Varti in Management of Nadivrana with Special Reference to Pilonidal Sinus.
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
- ASSESSMENT CRITERIA:
研究概览
简要总结
| Pilonoidal sinus is the disease that commonly arises in the hair follicles of the natal cleft of sacro coccygeal area, incidence is reported 26/100,000 population. Usually affects hairy adult males than females, it usually presents as an abscess or chronically discharging painful sinus tract. Inspite of mode of presentation, painful nature of condition causes significant morbidity, often with a protracted loss of normal activity. |
In Ayurveda shalyaja nadi vrana explained by Sushruta can be correlated with Pilonidal sinus by considering its clinical features.
In Modern Science, the management option varies from Phenol injection, lancing, exision of the tract and complex rotation flap. All these modalities are more invasive, not cost effecticve, require hospitalization and are not free from post operative complications and moreover they have high recurrence rate. Hence, it has been thought of to evaluate simple, safe and effective principle from the doctrines of Ayurveda for the management of nadivrana w.s.r.to Pilonidal sinus.
In Ayurveda different effective treatment modalities for Shalyaja Nadi Vrana have been explained. Many works have been done on ksharasutra at various cetres across the country. Mechanical introduction of kshara sutra is complex and painful procedure and it is aiso having some limitations in its use as in multiple sinuses. Varti kalpana is one of conservative line of management mentioned in classics and can be practiced at OPD level. After Varti Chikitsa patient can do his routine work without any disturbance.
In Bhaishajya Ratnavali, Snuhyadi Varti (Ref: .Bhaisajya Ratnavali,Chapter 51,Bhagandharrogadikara adyaya,p839) is mentioned for treatment of Nadivruna and Bhagandara1
As there is recurrence with existing surgical and other modalities of Modern Science, the need of the hour is to search for an effective and innovative treatment modality which can fulfill criteria of an ideal treatment which can prevent recurrence, cost effective and doesnot require hospitalization.
Varti Chikitsa has been ear marked by all the Acharyas and is found to be very effective in Nadi Vrana and also to avoid its recurrence. Therefore, in the present study, it has been planned to evaluate the efficacy of Snuhyadi Varti in the screened patients of Nadi Vrana wsr to Pilonidal Sinus and its efficacy will be assessed and compared with already established Apamarga Kshara Sutra varti in the management of Nadivrana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients presenting with classical signs and symtoms of nadivrana pain,discharge and a sinus in intergluteal region.
- •2.The age group between 16-60yrs 3.Both gender.
排除标准
- •1.Congenital sinus 2.Pilonidal sinus with systemic diseas DM,Bleedig disorder, AIDS,Tuberculosis Actinomycosis.
- •3.Osteomyelitis followed by sinus 4.Patient having Neoplastic Sinus 5.If the sinus tract is more than10 cm.
结局指标
主要结局
ASSESSMENT CRITERIA:
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
Subjective parameters.
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
1 Pain-is asseed on visual analog scale.
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
2 Burning sensation
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
3 Itching sensation.
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
Objective parameters
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
4Discharge
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
5Induration
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
6Length of the tract
时间窗: Patient is assessed for above said parameters on 6th weeks. The observations will be recorded in the proforma of case sheet. | Management is terminated after 6 weeks of the commencement of the therapy and to check the recurrence of the disease 3 months follow up will be done fortnightly.
次要结局
- Incidence of the Patients with classical signs and symtoms of nadivrana (pilonidal sinus)(in the OPD and)