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CTRI Number  CTRI/2025/02/080948 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To know the action of Nyagrodhapatra Lepa application By Comparing with Sooranadhi Lepa In pile masses  
Scientific Title of Study   A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Nyagrodhapatra Lepa With Sooranadhi Lepam In The Patients Of Arshas(II&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  Posam SivaPriyanka 
Designation  Post Graduate Scholar 
Affiliation  S. V. Ayurvedic College and Hospital 
Address  Room no.43 2nd Floor,Department Of Shalya Tantra,S.V.Ayurvedic College and Hospital SVIMS CAMPUS,Tirupati.
chittoor
Chittoor
ANDHRA PRADESH
517501
India 
Phone  07702557104  
Fax    
Email  posamsivapriyanka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDNagamani 
Designation  Associate Professor 
Affiliation  S. V. Ayurvedic College and Hospital 
Address  Department Of Shalya Tantra,S.V.Ayurvedic College and Hospital SVIMS CAMPUS,Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  07702557104  
Fax    
Email  mani.ayu99@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrDNagamani 
Designation  Associate Professor 
Affiliation  S. V. Ayurvedic College and Hospital 
Address  Department Of Shalya Tantra,S.V.Ayurvedic College and Hospital SVIMS CAMPUS,Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  07702557104  
Fax    
Email  mani.ayu99@gmail.com  
 
Source of Monetary or Material Support  
S.V. Ayurvedic College and Hospital SVIMS CAMPUS,Tirupati,Andhra Pradesh 517501 
 
Primary Sponsor  
Name  S.V. Ayurvedic College and Hospital 
Address  SVIMS CAMPUS,Tirupati,Andhra Pradesh 517501 
Type of Sponsor  Private 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 
Dr POSAM SIVAPRIYANKA  S.V.Ayurvedic College and Hospital  Department Of Shalya Tantra,S.V.Ayurvedic College and Hospital SVIMS CAMPUS,Tirupati.
Chittoor
ANDHRA PRADESH 		 07702557104

posamsivapriyanka@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
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: basavarajeeyam, Procedure details: Procedure Reference: basavarajeeyam, Procedure details: The patient will be laid down in lithotomy position.The perianal part is painted and draped with sterilized cut sheet.Haemorrhoidal mass circumference is measured with thread. After cleaning the pile mass with gauze pieces,sooranadhi lepam where Sooranakanda, haridra,chitramula,tankana and guda are mixed well and rubbed with aranala.kept in site for a period of 10-15 minutes for 14 days once daily and followup will be done in an interval of 7th,15th,21st day upto one month.Cleaned by sterile water.))
(1) Medicine Name: pancasakara churna,, Reference: ayurveda sara sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Months
(2) Medicine Name: triphala guggulu, Reference: sarangadhara samhitha, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 1 Months
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: basavarajeeyam, Procedure details: The patient will be laid down in lithotomy position.The perianal part is painted and draped with sterilized cut sheet.Haemorrhoidal mass circumference is measured with thread. After cleaning the pile mass with gauze pieces, Nyagrodhapatra lepam where nyagrodha bhasma mixed tila tailam will be applied in sufficient quantity and kept in site for a period of 10-15 minutes for 14 days once daily and followup will be done in an interval of 7th,15th,21st day upto one month.Cleaned by sterile water.)
(1) Medicine Name: pancasakara churnam, Reference: ayurveda sara sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Months
(2) Medicine Name: triphala guggulu , Reference: sarangadhara samhitha , Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 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 and Malignancy.
2.Pregnant women
3.Chronic kidney diseases.
4.Tuberculosis on Anti Tuburcular Treatment
5. 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 
1.To Evaluate The Efficacy Of Nyagrodhpatra lepa In Management Of Arshas.
2.To Know The Role Of Standard Sooranadhi Lepa In Arshas
3.To Compare The Efficacy Of Nyagrodhapatra Lepa With Sooranadhi Lepa In Arshas. 		 At baseline after completetion of treatment(1 to 14 days),21st day, 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find out safe,simple,effective and economical method of treating Arshas.
2.To find out whether this study drug regress the size of arshas and prevents the recurrence of arshas. 		 Group A:On everyday for 14 days and then follow up will be in an interval of 15th,21st day upto 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)   24/02/2025 
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="0"
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 disorders. The great Indian surgeon "Sushruta" known as father of Surgery has described Arshas in Sushruta Samhita, Nidana Sthana 2nd chapter and its Chikitsa in Chikitsa Sthana 6th chapter. He considered Arshas as one of the "Ashta Mahagada" means diseases which are very difficult to treat. Arshas was referred as Durnama or Darunakam, the name itself indicates bad. It is a disease that tortures the patient like an enemy, which afflicting mankind for thousands of years. 
 According to Madhavakara, the disease which kills a man like an enemy is called Arsha. 
 In modern concept Arshas can be compared with haemorrhoids/piles. Haemorrhoids is a Greek word derived from two words “Haem” =blood ,”Rhoos” = flow, means that blood flows and another is Pile. Pile is a latin word derived from ‘Pile’ that denotes the ball. 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 name Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse & discharge . 
 Bleeding, pain and prolapsed mass are the three main complaints for which the patient of haemorrhoids usually seeks medical advice.If not treated properly it may lead to complication like haemorrhage , thrombosis, fibrosis, strangulation, suppuration, portal pyaemia etc.,
There are so many procedures for the management of the disease such as sclerotherapy, Rubber band ligation, Cryosurgery, Haemorrhoidectomy etc., But Ayurveda is well known for the treatment of arshas for its negligible rate of recurrence, cost effective, less chances of pain, haemorrhage, infection & anal incontinence. Ayurveda pronounced a comprehensive chikitsa for arshas includes medicinal , surgical as well as para surgical treatments as prevailing today . 
Susruta advocates the management of arshas under four principal therapeutic measures .They are as follows: 1.Oushada karma (Medical Management) 2.Shastra karma (Surgical management) 3.Kshara karma (Chemical cauterization) 4.Agnikarma (Thermal cauterization).
 It is manifested due to improper diet, prolonged standing & faulty habits of defecation causing derangement of tri-doshas, mainly vata dosha. Vitiated doshas localizes in gudavali pradhana dhamani & mamsadhara kala & vitiates tvak, mamsa, meda & rakta, resulting in the annavaha sroto dushti. These vitiated dosas moves in downward direction , reaches guda and produces sprouts of muscles in guda vali . These sprouts are called Arshas. 
 The ancient acharyas i.e., susrutha,charaka, chakradutta,vangasena were explained many curative measures for management of arshas. Among them local application is also a method with good cure rate and well tolerance. ShalyaTantra, the integral part of Ayurvedic system contains detailed description of Shastiupakramas. Alepa is mainly used for the shamana of local kupitha doshas and reduces signs and symptoms which are explained in Sushruta Samhita Chikitsa Sthana Dvivraniya adhyaya. 
 According to Basavarajeeyam,Nyagrodha patra lepa mentioned in arshas chapter.
 By application of NYAGRODHAPATRA LEPA prepared by nyagrodhapatra burnt and made into ashes and mixed with oil and applied over pile mass .This subsides haemorroids. 
 In the present clinical study of Nyagrodhapatra lepa is taken from reference of Basavarajeeyam(ARSHOROGANIDANALAKSHANACHIKITSADYAH,53rd shloka).The ingredients Nyagrodha patra and Tila tailam. 
Thus the present study is entitled as A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF NYAGRODHAPATRA LEPAM WITH SOORANADHI LEPAM IN THE PATIENTS OF ARSHAS (II &III DEGREE HAEMORRHOIDS).
 
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