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CTRI Number  CTRI/2022/07/044239 [Registered on: 21/07/2022] Trial Registered Prospectively
Last Modified On: 14/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative clinical study on the effect of Chincha Swarasa Prakshalana and Nimbuka Swarasa Prakshalana as Paschat Karma of Apamarga Kshara karma in Abhyantara Arshas 
Scientific Title of Study   Comparative clinical study on the effect of Chincha Swarasa Prakshalana and Nimbuka Swarasa Prakshalana as Paschat Karma of Apamarga Kshara karma in Abhyantara Arshas 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagyashri Patil  
Designation  PG Student  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Shalya tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201

Hassan
KARNATAKA
573201
India 
Phone  9743058175  
Fax    
Email  bhagyashriap111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopikrishna B J  
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Shalya tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201

Hassan
KARNATAKA
573201
India 
Phone  9886360901  
Fax    
Email  drgopiboyapati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GOPIKRISHNA BJ 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Department of Shalya tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201

Hassan
KARNATAKA
573201
India 
Phone  9886360901  
Fax    
Email  drgopiboyapati@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 573201 Karnataka 
 
Primary Sponsor  
Name  Dr Bhagyashri Patil 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhagyashri Patil  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 573201  Department of Shalya tantra
Hassan
KARNATAKA 
9743058175

bhagyashriap111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-prakShAlana-karma, प्रक्षालन-कर्म (Procedure Reference: Sushruta Samhita, Procedure details: (Procedure Reference: Sushruta samhita, Procedure details: 20 Diagnosed subjects who fulfilled the inclusion criteria and willing to volunteer for the study will be taken and randomly allocated with Apamarga Kshara Karma followed by Nimbuka Swarasa Prakshalana in arshas and observed for 28 days))
(1) Medicine Name: Nimbuka Swarasa, Reference: sushruta Samhita, Route: Topical, Dosage Form: Swaras/ Juice, Dose: 10(ml), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-prakShAlana-karma, प्रक्षालन-कर्म (Procedure Reference: Sushruta Samhita, Procedure details: (Procedure Reference: Sushruta samhita, Procedure details: 20 Diagnosed subjects who fulfilled the inclusion criteria and willing to volunteer for the study will be taken and randomly allocated with Apamarga Kshara Karma followed by Chincha Swarasa Prakshalana in arshas and observed for 28 days))
(1) Medicine Name: Chincha Swarasa, Reference: Sushruta Samhita , Route: Topical, Dosage Form: Swaras/ Juice, Dose: 10(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Apamarga Kshara Karma followed by Chincha Swarasa Prakshalana is effective in the management of Arshas  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 
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