“MANAGEMENT OF PILES(2ND DEGREE) BY USING KSHARA (AYURVEDIC INTERVENTION) AND SCLEROTHERAPYâ€

Phase 2/3

Not yet recruiting

• Conditions: Second degree hemorrhoids. Ayurveda Condition: ARSAH,

• Registration Number: CTRI/2022/05/042647
• Lead Sponsor: All india institute of Ayurveda

Brief Summary

**INTRODUCTION :**

Sushruta has mentioned four folds therapeutic procedure in the management of Arsha, namely Bheshaja karma (medicinal treatment), Kshara karma (use of caustics), Agnikarma (use of heat) and Shastra karma (surgery).i Kshara is a caustic material, alkaline in nature obtained from the ashes of medicinal plants. It is a milder procedure compared to Shastra Karma (Surgery) and Agnikarma (Thermal cautery). Kshara is described as one among the Anu-shastra or Upayantras. It is said to be superior among all the sharp and subsidiary instruments by virtue of its Chedana (Excision), Bhedana (incision), Lekhana (scraping) as well as Tridoshaghna properties. Kshara Karma is indicated in Arsha Chikitsa and use of Apamarga Kshara is mentioned by Chakradutta (Arsha Chi.10) iii. Preparation of Kshara is thoroughly described in Sushruta Sutra Sthan.

**NEED OF STUDY  :**

The present study is an attempt for the fulfilment of the above need with Pratisaraneeya Kshara application, prepared from the plant of Apamarga (Achyranthus aspera). It consists a Comparative clinical evaluation of Pratisaraneeya Kshara application with Sclerotherapy as a control group in management of 2nd Degree Hemorrhoid

**SAMPLE SIZE :**

Assuming 95% confidence level 80º two-sided test calculated sample size is 33. With the assumption of 10% dropout, we will take 37 patients per groups.

**INCLUSION CRITERIA** 1) Patients of age between 20 - 60 years age group. 2) Patients presenting with signs and symptoms of 2 nd degree internal Hemorrhoids. - Prolapse that goes back in on its own - Pain less bleeding 3) Patient willing for Kshara therapy / Sclerotherapy

**EXCLUSION CRITERIA:** 1) Patients with 3 rd or 4 th degree internal haemorrhoids and Bahya Arsha (ExternalPiles). 2) Patients contraindicated for Kshara Karma. 3) Infective / Inflamed / Thrombosed Piles.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-05
• Study Start: 2022-06-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 1. Patients of age between 20.
• 60 years age group. 2) Patients presenting with signs and symptoms of 2 nd degree internal Hemorrhoids.
• Prolapse that goes back in on its own.
• Pain less bleeding 3) Patient willing for Kshara therapy / Sclerotherapy.

Exclusion Criteria

• 1. Patients with 3 rd or 4 th degree internal haemorrhoids and Bahya Arsha (ExternalPiles).
• 2. Patients contraindicated for Kshara Karma.
• 3. Infective / Inflamed / Thrombosed Piles.
• 4. Arsha associated with one or more of the following problems: Ano-rectal & other malignancy Fissure and fistula-in-ano Rectal prolapse Uncontrolled Hypertention Diabetes mellitus Acute/chronic ulcerative colitis Crohn’s disease H/o Tuberculosis HIV, HBsAg & VDRL Positive cases Other metabolic disorders Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Reduction in size of pile mass and stoppage of bleeding.	1) Reduction in size of pile mass and stoppage of bleeding in 4 weeks. | 2) the effectiveness in sign & symptoms of piles after application of | Teekshna Apamarga Kshara application and Sclerotherapy in 4 weeks.
2) To record the effectiveness in sign & symptoms of piles after application of	1) Reduction in size of pile mass and stoppage of bleeding in 4 weeks. | 2) the effectiveness in sign & symptoms of piles after application of | Teekshna Apamarga Kshara application and Sclerotherapy in 4 weeks.
Teekshna Apamarga Kshara application and Sclerotherapy.	1) Reduction in size of pile mass and stoppage of bleeding in 4 weeks. | 2) the effectiveness in sign & symptoms of piles after application of | Teekshna Apamarga Kshara application and Sclerotherapy in 4 weeks.

Secondary Outcome Measures

Name	Time	Method
1) Comparative outcome of Apamarga Pratisarneeya Kshara and Sclerotherapy	2)Improvement in quality of life.

Trial Locations

Locations (1)

All India institute of Ayurveda, sarita vihar, New Delhi, 110076; 🇮🇳 South, DELHI, India

All India institute of Ayurveda, sarita vihar, New Delhi, 110076

🇮🇳South, DELHI, India

Deepak Khundia

Principal investigator

7404311012

deepakkhundia340@gmail.com