A CLINICAL EFFICACY OF PALASHA KSHARASUTRA PREPARED WITH ARKA KSHEERA IN THE MANAGEMENT OF BHAGANDARA (FISTULA-IN-ANO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Palasha Ksharasutra prepared with Arka-ksheera is effective in the management of Bhagandara (Fistula-in-Ano)
研究概览
简要总结
Bhagandarais one of the most common ailments pertaining toano-rectal region. This disease causes discomfort and pain to patient, whichcreates problems in routine work. It is correlated with Fistula-in-ano andis encountered under Ashtamahagada. The importance of this diseasewas first realized by Acharya Sushruta (800-1000 B.C.) thus, hedescribes as:
तेतà¥à¤à¤—गà¥à¤¦à¤µà¤¸à¥à¤¤à¤¿à¤ªà¥à¤°à¤¦à¥‡à¤¶à¤¦à¤¾à¤°à¤£à¤¾à¤šà¥à¤šà¤à¤—नà¥à¤¦à¤°à¤¾à¤‡à¤¤à¥à¤¯à¥à¤šà¥à¤¯à¤¨à¥à¤¤à¥‡à¥¤
अपकà¥à¤µà¤¾**:पिडका:,पकà¥à¤µà¤¾à¤¸à¥à¤¤à¥à¤à¤—नà¥à¤¦à¤°à¤¾:॥(सà¥.नि.४/४)**
Thelitral meaning of Bhagandara is Darana , which means splitting up or burstingup.. It clearly indicates that bursting of pakwa pidaka eitherresults into communicating track between Bhaga,Guda & Vasti pradesha withsurrounding(perianal) structures.
As the wound is inanal region which is more prone to infection, thus takes long time to heal andthe condition remains troublesome. Modern operative procedures often lead tocomplications like recurrences and incontinence.
To alleviate such problems in the management ofthis disease, it was thought to find out alternative technique to treat thesecases without operative complications.
Keeping in view of these complications,AcharyraSushruta mentioned ksharasutra application in the management of bhagandara. Asksharasutra has both cutting and healing properties. Acharya Susruthain sutrasthana ksharapaka vidhi adyaya 11th chaptermentioned various kshariaya drugs, in which Palasha and Arkaare among them selected for the present study.
**अथानेनैवविधनेनकà¥à¤Ÿà¤œà¤ªà¤²à¤¾à¤¶à¤¾à¤¶à¥à¤µà¤•à¤°à¥à¤£à¤ªà¤¾à¤°à¤¿à¤à¤¦à¥à¤°à¤•à¤¬à¤¿à¤à¥€à¤¤à¤•à¤¾à¤°à¤—à¥à¤µà¤§**…………….
…………समूलफलपतà¥à¤°à¤¶à¤¾à¤–ादहेतà¥à¥¥(सà¥.सà¥.११/१२)
To assess the relative efficacy of Palasha ksharasutraprepared with arka ksheera in the management of Bhagandara is proposed for thepresent study.
a. Inclusive Criteria
1.) Patientsof Bhagandara age between 16-70 years, irrespective sex, religion, occupation,economic status.
2.) Patientswith low anal fistula.
3.) Patientswith one fistulous tract.
b. Exclusive Criteria
1.) Patientswith high anal fistula.
2.) Patientsbelow the age of 16 years.
3.) Patientsof Bhagandara associated with diseases like Tuberculosis, Diabetic mellitus, CaRectum, HBsAg, HIV will be excluded from the study, after thorough history andclinical information.
4.) Patientsof low anal fistula secondary to the ulcerative colitis and Crohn’s diseases.
iii. OperationalDefinitions / Techniques employed
Being a clinicalstudy, 100 patients will be selected by Simple Randomized Sampling procedure.All the patients will be screened out by inclusive and exclusive criteria andregistered for clinical trial in specially prepared research case sheet anddivided in two equal groups.
Group 1 (Trial Group):
50 patients of Bhagandara willbe treated with Palasha Ksharasutra prepared with arka ksheera.
Group 2 (Control Group):
50 patients of Bhagandara willbe treated with Standard Ksharasutra.
Materials required: -
Sterile Gloves, Gauze piece, Cotton swab, 2%lignocaine gelly, Probe, Proctoscope, 2-0 no. Barbour’ssurgical linen thread,Ksharasutra, Cabinet, U.V.light, Apamarga kshara, Palasha kshara.
Procedure:
The trial PalashaKsharasutras are prepared with thehelp of Barbour’s surgical Lenin thread no.20, which will be smeared for 11coatings of fresh Arka ksheera, 7 coatings of Arkaksheera and Palashakshara and 3 coatings of Arka ksheera and Haridra churna bystandard Ksharasutra procedure.
Duration andfollow up of the Study:
In both thegroups Ksharsutra will be replaced weekly. The total duration of the study willbe 6 weeks.
Patients will be called on every week and the cutting rate will be assesed andrecorded in a specially prepared case sheet. Observations will be analyzed onthe basis of assessment parameter (both subjective and objective) clinicallyand scientifically before treatment and after treatment on the 1st,2,3 ,4 ,5 and 6th week. Finally the results will bestatistically evaluated with the help of paired‘t’ test within the group forits significance.
Follow up of each patient will be made for a period of6 months after treatment with an interval of every month.
| BT G1 vs AT G1 |
will be assessed
AT G1 vs AT G2
will be compared
|BT G2 vs AT G2
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of Fistula in ano irrespective sex, religion, occupation and economic status.
- •2.Patients with low anal fistula 3.Patients with one fistulous tract.
排除标准
- •1.Patients with High anal fistula 2.Patients of Low Anal Fistula secondary to Ulcerative Colitis & CROHNS disease 3.Patients of Fistula in Ano associated with diseases like TB, DM, Ca Rectum, HbsAg and HIV.
结局指标
主要结局
Palasha Ksharasutra prepared with Arka-ksheera is effective in the management of Bhagandara (Fistula-in-Ano)
时间窗: 6 weeks
次要结局
- Palasha Ksharasutra prepared with Arka-ksheera is equally effective as Apamaarga Ksharasutra in the management of Bhagandara (Fistula-in-Ano)(6 weeks)