Comparative clinical study on the effect of Chincha Swarasa Prakshalana and Nimbuka Swarasa Prakshalana as Paschat Karma of Apamarga Kshara karma in Abhyantara Arshas

Phase 2/3

Not yet recruiting

Conditions: Unspecified hemorrhoids. Ayurveda Condition: ARSAH,

Registration Number: CTRI/2022/07/044239

Lead Sponsor: Dr Bhagyashri Patil

Brief Summary: **SUMMARY-**

Arshas is compared to hemorrhoids in the contemporary science. Dilated plexus of haemorrhoidal veins in relation to anal canal is called as hemorrhoids.Arshas which are Mridu, Prasrita, Avagadha, Uchrita should be treated by Kshara Karma. According to Susrutha Acharya the effect of Kshara is considered as it can replace Shastra and Anushastra, does the functions of Chedana, Bhedana and Lekhana Karmas without using Shastras. In Sushruta Chikitsa Sthana 6th chapter Arshas Chikitsa Adhyaya, Acharya explains Phalamla as Prakshalana Dravya in Kshara Karma.

The studies so far have been carried out by the use of Apamarga, Chitraka, Aragwadha, Arka etc. in various centers in India and less attention has been paid to Prakshalana Dravyas of Kshara Karma particularly in Arshas. These Ksharas though having efficacy but still cause discomfort and pain after application especially in Apamarga Pratisaraneeya Kshara followed by Nimbuka Swarasa Prakshalana. Therefore there is a need to evaluate the efficacy of other drugs having neutralizing property of Kshara. Hence, for this study, Chincha Swarasa is taken as Prakshalana Dravya in Apamarga Pratisaraneeya Kshara Karma to evaluate its efficacy in Abhyantara Arshas.

Chincha has Krimighna and Ropana properties and have chemical constituents like tamarindienol, hordenine and epicatechin which helps in antifungicidal and antimicrobial action. Anal canal is prone to contamination during postoperative period because of which there will be delaying of Ksharadagdha Vrana Ropana. Chincha is abundantly available, with a single plant we can get large amount of fruits to prepare Chincha Swarasa. So Chincha is selected as Prakshalana Dravya in Paschat Karma of Apamarga Kshara Karma.

**OBJECTIVES-**

1. To evaluate the clinical efficacy of Apamarga Pratisaraneeya Kshara followed by Prakshalana with Chincha Swarasa in the Management of Abhyantara Arshas.

2. To compare the clinical efficacy of Apamarga Pratisaraneeya Kshara followed by Prakshalana with Chincha Swarasa and Nimbuka Swarasa in the Management of Abhyantara Arshas.

**METHODOLOGY:** Interventional clinical study

**PRE-OPERATIVE PROCEDURE**:

After getting surgical fitness, the patients will be kept nil per oral 8 hours prior to surgery. Informed written surgical consent will be made to fill. Part preparation will be done and bowel preparation will be done by proctoclysis enema and intramuscular injection tetanus will be given 1 hour prior to surgery.

**OPERATIVE PROCEDURE:**

The patient is in lithotomy position and the part is cleaned with aseptic solutions and draping done after spinal or local anesthesia. Arshoyantra smeared with Taila is to be introduced in to the anus and assess the various haemorrhoids. The pile mass should be gently scraped or rubbed and cleaned with cotton swab with warm water. Then the Apamarga Kshara will be applied with the help of Darvimukha Shalaka. After applying the Kshara, the anal canal kept closed by the hand for a period of hundred Matra Kala or till the haemorrhoids turns to the colour of Pakwa Jambhuphala. After this process, the pile mass will be washed with Chincha Swarasa. Later the anal pack will be done with Yashtimadhu Taila. All the pile masses will be applied in simultaneously. Yashtimadhu Taila packing removing after 8 -10 hrs.

**POST OPERATIVE CARE:**

The patient will be kept on proper analgesics, intravenous fluids and intravenous antibiotics. Normal diet will be allowed after assessing the condition. Triphala Kashaya for Sitz Bath and Matra Basti with Yashtimadhu Taila, internal medicines like Triphala Guggulu, Gandhaka Rasayana and Haritaki tablet will also be given.

**FOLLOW UP STUDY:**

Follow up of patient will be done on 3rd day to assess the post-operative recovery and on 7th day, 14th day, 21st day and 28th day to assess the effect of treatment. Thereafter on 3rd month to evaluate recurrence if any.

**DIAGNOSTIC CRITERIA:**

Diagnosis will be made on the basis of signs and symptoms and physical examination by performing per rectal examination i.e. inspection, digital rectal examination and proctoscopic examination. Arshas with following properties will be taken:

1.First and second degree internal haemorrhoids with bleeding

2.Mridu (soft)

3.Prasrita (spreaded)

4.Avagadha (deep rooted)

5.Uchrita (elevated)

**ASSESSMENT CRITERIA:**

Assessment is based on the subjective and objective parameters, which are formulated for Arshas assessed before and after treatment.

1.     Ruja (Post-operative pain)

2.     Raktasrava (Bleeding)

3.     Constipation

4.     Size of the pile mass

5.     Colour of haemorrhoids

Rate of sloughing of haemorrhoids

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

The following will be the main inclusion criteria for the study, 1.Arshas which are of Mridu (soft), Prasrita (spreaded), Avagadha (deep), Uchrita (elevated).
2.First and second degree internal haemorrhoids 3.Patients above the age of 18 years and below 70 years irrespective to caste, sex, religion and socio-economic status 4.Patient ready to participate and sign the informed written consent.

Exclusion Criteria

The following will be the main exclusion criteria for the study, 1.Patients with carcinoma of rectum and anal canal.
2.External haemorrhoids and interno-external haemorrhoids.
3.Patients with other systemic illness like IBS, Ascites, chronic liver disease with portal hypertension, HBsAg positive & HIV positive patients.
4.Pregnant and lactating women.
5.Patient with impaired cardiac, renal and hepatic function.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apamarga Kshara Karma followed by Chincha Swarasa Prakshalana is effective in the management of Arshas	28 days

Secondary Outcome Measures

Name	Time	Method
There is significant difference in the Chincha Swarasa Prakshalana and Nimbuka Swarasa Prakshalana as a Paschat Karma of Apamarga Kshara Karma in the management of Arshas	28 days

Trial Locations

Locations (1): Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201
🇮🇳
Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201
🇮🇳Hassan, KARNATAKA, India
Bhagyashri Patil
Principal investigator
9743058175
bhagyashriap111@gmail.com