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临床试验/CTRI/2019/07/020369
CTRI/2019/07/020369尚未招募2 期

A COMPARATIVE CLINICAL STUDY OF VASA PRATISARANEEYA TEEKSHNA KSHARA AND APAMARGA PRATISARANEEYA TEEKSHNA KSHARA IN THE MANAGEMENT OF ABHYANTARA ARSHA (INTERNAL PILES)

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Patients of either sex of 20 to 65 years old diagnosed as Abhyantra arsha(Int. piles) will be selected for relief in sign and symptoms.

研究概览

简要总结

Sushruta, the author of Sushruta Samhita, available text in Ayurveda surgical practice, has included Arsha in Ashta-Mahagada1.   The drastic change in lifestyle has caused rapid increase in the prevalence of this disease. The incidence rate of this disease is high among people with old age. At least fifty percent of the people over the age fifty years have some degree of symptoms related to piles2. In Sushruta Samhita, the treatment modality for Arsha has been divided into four categories3 i.e. Bheshaja Chikitsa (Medical treatment), Kshara Karma (Caustic Therapy), Agnikarma (Thermal cautery Therapy) and Shastra Karma (Surgery). Kshara Karma is indicated in Arsha which are Mridu, Prasrita, Avagada and Uchchhrita4. Sushruta explained two types of Kshara in treatment of Arsha i.e. Paneeya and Pratisaraneeya5. Sushruta has mentioned twenty six drugs for the preparation of Pratisaraneeya Kshara6. Among them I have selected Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha (Internal piles).                  I.  AIM  To evaluate and compare the efficacy of Vasa Pratisaraneeya  Teekshna Kshara  and  Apamarga Pratisaraneeya Teekshna Kshara  in the management of  Abhyantara Arsha.

II. OBJECTIVES                                                                                                                                                   1. To evaluate the effect of Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha.  2. To compare the effect of Vasa Pratisaraneeya Teekshna Kshara and Apamarga Pratisaraneeya Teeskhna Kshara in the management of  Abhyantara Arsha.  3. To study the prepared Vasa Pratisaraneeya Teekshna Kshara phytochemically.

Arms  Assigned  Intervention Group A - 15 Patients withI0, II0& III0 Abhyantara Arsha. Apamarga Pratisaraneeya   Teekshna Kshara Control group Procedure: Apamarga Pratisaraneeya Teekhshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass for until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa. Group B - 15 Patients with I0, II0&III0Abhyantara Arsha. Vasa Pratisaraneeya Teekshna Kshara Trial group Procedure: Vasa Pratisaraneeya Teekshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa.                                                                                                                       Post-Operative Treatment

1.  Triphala Guggulu 500 mg. twice daily after meal for 7 days

  1. Laxative- Haritaki Choorna 5 gm. at bed time for 7 days with luke warm water.

  2. Warm Sitz bath by Tankan Bhasma 1/2 tsf - twice daily for 7 days

  3. Yasthimadhu Taila Matra Basti 15 ml. twice daily for 7 days.

  4. Yasthimadhu Taila for P/R Pichu twice daily for 7 days                                                                                                                                                                                                                                                Method of Preparation of Apamarga / Vasa Pratisaraneeya Teekshna Kshara15:            The Panchanga of Apamarga / Vasa plant will be collected, dried up and burnt. Then this ash will be collected and mixed with six times of water and filtered 21 times. When the filtrate shall be clean and clear like Gomutra Varna and it will be kept on mild fire and reduced to 2/3rd. Then red hot Shukti (weight 1/10th part of ash) shall be added into the filtrate solution and will be continuously stirred well until it shall reduce to 1/3rd. This shall be further heated up by adding Chitraka Kalka (weight 1/10th part of Shukti). Thick solution will be obtained and this is known as Apamarga /Vasa Pratisaraneeya Teekshna Kshara. It will be collected and stored in air tight container.                                                                                                                                         Procedure of Kshara application :

The patient will be placed in lithotomy position on operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with sterilized cut sheet. After then local infiltration anesthesia will be given. With the help of Ghrita smeared Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vasa or Apamarga Kshara will be applied over the pile mass with the help of Darvimukha Shalaka under direct vision. As soon as applying the Kshara, the opening of the Arsho Yantra will be closed by cotton swab and wait for a period of hundred Matra Kala. When the colour of pile mass is looked like Pakwa Jambhuphala, the extra Kshara will be washed out with freshly prepared Nimbu Swarasa. Later the anal packing will be done with Yashtimadhu Taila Pichu. All the pile masses will be applied in a single sitting.

13

ASSESSMENT CRITERIA

A.  Subjective Parameters:  a. Ruja  (Post operative pain)  b. Raktashrava (Bleeding)

B.  Objective Parameter:

a.    Size of the pile mass. b. Colour of pile mass. c. Anal sphincter tonicity (by Hemantha Kumar Modified Sphincterometer)

C.  Secondary Outcome Measures   a. Recovery time.  b. Time to return to work.   c. Parental/patient satisfaction.

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
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of Internal Arsha between the ages of 20 yrs to 65 yrs.
  • ï‚· Patients of Internal Arsha which are Mridu, Prasrita, Avagada (Deep) and Uchchhrita (Projected).
  • ï‚· Patients of Internal Arsha having Pittaja and Raktaja origin.

排除标准

  • Patients of Arsha, age less than 20 yrs.
  • and more than 65 yrs.
  • ï‚· Patients with other systemic illness like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis and Retrovirus positive.
  • ï‚· Grade IV Internal Piles.
  • ï‚· External piles and other associated Ano-rectal diseases.
  • ï‚· Infective and Neoplastic conditions of rectum, Rectal prolapse.
  • ï‚· Pelvic pathology and Pregnancy.

结局指标

主要结局

Patients of either sex of 20 to 65 years old diagnosed as Abhyantra arsha(Int. piles) will be selected for relief in sign and symptoms.

时间窗: 4 WEEK

次要结局

  • Recovery time. b. Time to return to work. c. Parental/patient satisfaction.(30 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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