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CTRI Number  CTRI/2024/10/075458 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative study of Katutumbi bijadi Guda varti with Apamarga Ksharasutra Ligation in patients of Arshas. 
Scientific Title of Study   A Randomized Controlled clinical study of Katutumbi bijadi Guda varti with Apamarga Ksharasutra Ligation in the patients of Arshas(II and III Degree Haemorrhoids) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanneeru Lakshmi Gowri 
Designation  Post graduate scholar 
Affiliation  S V Ayurvedic college and Hospital 
Address  Department of Shalya Tantra S V Ayurvedic college and Hospital SVIMS Campus Tirupati Chittoor

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9000557928  
Fax    
Email  laksmigowri1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K V Vijaya Bhaskara Reddy 
Designation  Professor and HOD 
Affiliation  S V Ayurvedic college and Hospital 
Address  Department of Shalya Tantra S v Ayurvedic college and Hospital SVIMS Campus Tirupati Chittoor

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9849451333  
Fax    
Email  drkvbreddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tanneeru Lakshmi Gowri 
Designation  Post graduate scholar 
Affiliation  S V Ayurvedic college and Hospital 
Address  Department of Shalya Tantra S V Ayurvedic college and Hospital SVIMS Campus Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9000557928  
Fax    
Email  laksmigowri1997@gmail.com  
 
Source of Monetary or Material Support  
S.V. Ayurvedic College and Hospital,SVIMS CAMPUS,Tirupati,Andhra Pradesh-517507  
 
Primary Sponsor  
Name  S.V. Ayurvedic College and Hospital 
Address  SVIMS CAMPUS, Tirupati, Andhra Pradesh 517507 
Type of Sponsor  Government medical college 
 
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 
Tanneeru Lakshmi Gowri  S.V. Ayurvedic College and Hospital  OP number-5, Department of Shalya Tantra, S.V. Ayurvedic College and Hospital, SVIMS CAMPUS, Tirupati. ANDHRA PRADESH 517507 India
Chittoor
ANDHRA PRADESH 
9000557928

lakshmigowri1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of TTDs S.V. Ayurvedic College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-gudavarti, गुदवर्ति (Procedure Reference: Bhaisajya Ratnavali 9/14, Procedure details: The patients who were diagnosed with Arshas are to be advised to undergo the routine investigations & viral markers. After checking all the reports thoroughly, the patient should advised to consume light diet on the day of treatment & should be conform about clear evacuation of bowels. After Conforming about the bowel passage, the patient should made to be lie down in a left lateral position on the examination table, then local part should be cleaned with swabs & then mopped dry with sterile gauze. Then anal canal should be lubricated with Go gritha. Afterwards katutumbi bijadhiadhi Gudavarti should be kept in the anal canal. After 15 min, the part should be washed thoroughly & then local packing has to be done. Patients should be advised to take sitz bath twice daily. All the patients should be advised to take buffalo curd diet during course of treatment. This procedure is repeated for two consecutive days. Then after completion of 3 days of treatment with Katutumbi bijadi gudavarti, progress of the patient is observed for every week for 1 month. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients having signs and symptoms of Arshas.
2)Patients with age ranging from 18 years to 65 years with irrespective of gender.
3)Patients having II & III degree Haemorrhoids. 
 
ExclusionCriteria 
Details  1)Concomitant Ano-rectal conditions like Fistula-in-Ano, Fissure - in -Ano, ulcerative
colitis, Malignancy.
2)Pregnant women.
3)Patients of Portal hypertension.
4)Patients of Chronic kidney diseases.
5)Patients of Tuberculosis.
6)Patients of Inflammatory bowel disease.
7)Patients of Uncontrolled diabetes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To find out whether this study drug regress the size of Arshas and prevents the recurrence of Arshas.  3 days 
 
Secondary Outcome  
Outcome  TimePoints 
To find out safe, simple, effective and economical method of treating Arshas.  1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   30/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In Ayurveda, since Vedic period Arshas has been the main area of concern among anorectal disease. The great Indian Surgeon Susrutha known as father of surgery has described Arshas in Susrutha samhitha Nidana sthana 2 nd chapter (K.R..Srikantha Murthy,2017, p.233) and its chikitsa in Chikitsa sthana 6th chapter. He considered Arshas as one of the Astha Mahagadas means diseases which are very difficult to treat. Arshas is an torious for its troublesome pain like enemy, which afflicting mankind for thousands of years.
           This condition can be correlated with Haemorrhoids in modern science, in which dilated veins within the anal canal in the sub-epithelial region formed by radicals of superior, middle and inferior rectal veins. Haemorrhoids are engorgement of the Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge.
            Acharya Susrutha has mainly narrated the four types of treatment modalities for successful management of Arshas viz., Bhesaja [Internal and external medications], Shastra [Surgical methods], Kshara [Caustic cauterization], and Agnikarma [Thermal cauterization].
           Despite of many more modern treatments like Rubber band ligation, Sclerotherapy, Photocoagulation, Cryosurgery, Haemorrhoidectomy, etc., Ayurveda is well known for the treatment of Arshas for its negligible rate of recurrence, cost effective, less chances of pain, Haemorrhage, infection and anal incontinence. 
            According to Bhaisajya ratnavali, only three applications of Gudavarti prepared by pounding Tumbi bija and Audbhida lavana with kanji alleviate Arshas. During the course of treatment, the patient is to be kept on Buffalo’s curd diet.
            Gudavarti are solid dosage preparations which are prepared by moulding or compression methods intended for its insertion into rectum. It facilitates vata anulomana and which there by eases the expulsion of Mala and also intended to exhibit udavarthahara karma. Katutumbi beeja is having katu vipaka and which has anti-thrombotic property makes bandana of sonitha srava. Because of having tikta rasa it acts on tvak and mamsa dhatu makes mamsa sthirikarana which may prevents degenerative process in collagen fibers and fibro-elastic tissue. That which may help’s in reducing the congestion and pooling of blood from the hamorrhoidal masses and increases the tone of vasculature so that mass start decreasing in size gradually and in the end it may completely shrinks the mass.
             There are several therapeutic reasons affecting bioavailability of drugs from rectal suppositories, one among these is to partly avoid hepatic first- pass elimination or metabolism following rectal administration. Colorectal absorption is a simple diffusion process through the lipoidal membrane in which there is carrier mediated mechanism. It is also believed that rectal pH of about 7.3 provides a convenient environment for the drug to be chemically stable on insertion. No issues with oral compliance of the patient thus avoiding nausea and vomiting. It also proves to be a convenient drug delivery option in patients especially with rectal complaints. The rectal temperature ia around 37.8ºC-38.9 ºC where as the melting point of this prepared Gudavarti is 36ºC which is easly soulbe in rectal temperature and hence play a good mode of action.
              Among the four treatment modalities in Arshas mentioned by susrutha, kshara karma and Agnikarma are considered as para-surgical procedures. These para-surgical procedures are having many advantages viz., They are simple, safe, effective, ambulatory and minimal or no complications, less time to study in hospital and minimal interference in patients routine work.
              Ksharasutra treatment is very suitable and acceptable as compared to prevalent methods in modern medical science. Even though, it has been accepted by medical society for its good efficacy in treatment of Bhagandara there is still need in of standardization of Ksharasutra Ligation in the treatment of arshas.The Ksharasutra ligation performs excision by virtue of its mechanical pressure and phytochemical cauterization effect and ligation is expected to reduce the engorgement and finally peels the lesion in the post operative period and may prove superior to the conventional Haemorrhoidectomy.
              The present study compares the efficiency of Katutumbi Bijadi Gudavarti with Apamarga Ksharasutra Ligation in the patients of  Arshas.
 
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