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临床试验/CTRI/2024/03/064299
CTRI/2024/03/064299已完成3 期

A comparative clinical study on the efficacy of Apamarga Teekshna Kshara application and Sclerotherapy in Arsha w.s.r to 1 st and 2 nd degree Heammoroids - An open labeled, randomized, controlled clinical trial.

Dr T Sushendra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Relief in synptomatology of 1st and 2nd degree internal heamorroids given below-

研究概览

简要总结

Methodology:

·         Study design: Randomized control clinical study.

·         Grouping: Patients shall be allotted into two groups by computer generated randomization chart.

Pre- operative procedures in Group A and Group B:

Ø  Enemawill be given in the before surgery.

Ø  Written informed consent will be taken before surgery.

Ø  Lignocaine 2 % sensitivity test will be done (0.1ml intradermal).

Ø  Inj. Tetanus Toxoid 0.5 ml intramuscular will be given to each patient.

Ø  Local part will be prepared (local shaving) before operation.

Operative procedure:

GROUP-A: (Apamarga Teekshna Kshara Application): Minimum 30 patients will be treated by Apamarga Teekshna Kshara application.

Methodology: In Lithotomy position, Under Local anesthesia with 2% xylocaine and adrenaline solution, the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The hemorrhoidal mass will be cleaned with normal saline and the Apamarga Theesksna Kshara will be applied on Hemorrhoidal mass. After 100 matra kala when the hemorrhoidal mass turns into Pakwa Jambu Phala Varna. The Kshara will be washed out with Citrus juice.

GROUP-B :( Sclerotherapy): A minimum of 30 patients will be treated by sclerotherapy.

Methodology: In Lithotomy position, Under Local anesthesia the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The Sclerosant solution (Inj 3 % Polidocanol) will be injected through a very fine needle directly into the submucosa of hemorrhoids. This procedure will be performed under the supervision of General Surgeon of  Mahagujarat Hospital, Nadiad, Gujarat.

Post operative: General Management in both the groups: (for 15 days)

·         Vital data like TPR, BP will be monitored and recorded.

·         Hot sitz bath was advised with 4 L of Panchavalkala Kwatha twice a day.

·         Triphala guggulu 500 mgwill be given twice a day after meal with luke warm water.

·         Eranda Bhrushta Haritaki Churna 5 g will be given at night with luke warm water.

·         10 ml Jatyadi Taila Matra Basti will be given in the morning.

·         Antibiotic (Tablet amoxicillin 500mg + potassium clavulanate 125mg 1 tablet after food twice a day) will be given in the initial 5 days.

· Dietary regimen

The patients will be directed to follow dietary restrictions according to the etiology of hemorrhoids. Apart from this, all the patients will be restrained from strong and spicy foods, coffee, tea, increased quantity of milk and milk products, condiments, and other food items. And advised to take a regular and proper fibrous diet with adequate quantity of water.

 Observation and Follow-up: Patient observation will be done on 1st, 7th, 14th, 21st and 28th day of treatment and follow up after 1 months of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • 1.Age- 18 to 60 years.
  • 2.Patients with 1st and 2nd degree internal Hemorrhoids having bleeding,pain and itching in anal region.
  • 2.1 Mrdu, Prasruta, Avagadha, Uchritani (soft, deep seated and elevated Hemorrhoids).
  • Controlled case of HTN, DM and Cardiac disorders.

排除标准

  • Age less than 18 years and more than 60 years
  • 3rd and 4th degree hemorrhoids
  • Rectal prolapse
  • Patients of Acute and Chronic anal fissure
  • Hemorrhoids associated with Fissure and fistula-in-Ano
  • Uncontrolled Hypertension, Diabetes Mellitus, Cardiac disorders
  • Ano rectal Malignancy.
  • Pregnant women
  • Hepatitis B, Tuberculosis, HIV & VDRL positive cases.

结局指标

主要结局

Relief in synptomatology of 1st and 2nd degree internal heamorroids given below-

时间窗: Before starting the procedure. | After the procedure at 1st ,7th,14th ,21st and 28th day.

1.Pain during defecation

时间窗: Before starting the procedure. | After the procedure at 1st ,7th,14th ,21st and 28th day.

2. Bleeding during defecation.

时间窗: Before starting the procedure. | After the procedure at 1st ,7th,14th ,21st and 28th day.

3. Itching around the perianal region.

时间窗: Before starting the procedure. | After the procedure at 1st ,7th,14th ,21st and 28th day.

次要结局

  • 1.VAS(2.Size of Hemorrhoid mass)

研究者

发起方
Dr T Sushendra
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

T Sushendra

J S Ayurved Mahavidyalaya and P D Ayurveda hospital.

研究点 (1)

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