FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075545 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of ayurvedic formulation in the management of arsha with reference to piles 
Scientific Title of Study   Randomised Controlled Clinical Study Of Efficacy Of Mushalyadi Yoga In the Management Of Arsha W.S.R To 1st and 2nd Degree Internal Haemorriods 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aniket Pruthviraj Pawar  
Designation  MS Shalyatantra Scholar  
Affiliation  Dr VJD GRAMIN AYURVED MAHAVIDYALAYA  
Address  Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur Tal Patur District Akola
Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola
Akola
MAHARASHTRA
444501
India 
Phone  9769111276  
Fax    
Email  aniket.pawar992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh B Belorkar  
Designation  Associate Professor (Shalya) 
Affiliation  Dr VJD GRAMIN AYURVED MAHAVIDYALAYA  
Address  OPD NO 18 Department of Shalya Tantra Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola
OPD NO 18 Department of Shalya Tantra Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola
Akola
MAHARASHTRA
444501
India 
Phone  7972681655  
Fax    
Email  ganeshbelorkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh B Belorkar  
Designation  Associate Professor (Shalya) 
Affiliation  Dr VJD GRAMIN AYURVED MAHAVIDYALAYA  
Address  OPD NO 18 Department of Shalya Tantra Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola
OPD NO 18 Department of Shalya Tantra Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola
Akola
MAHARASHTRA
444501
India 
Phone  7972681655  
Fax    
Email  ganeshbelorkar@gmail.com  
 
Source of Monetary or Material Support  
Department of shalya tantra Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur District Akola State Maharastra Country India pincode 444501 
 
Primary Sponsor  
Name  Dr VJD GRAMIN AYURVED MAHAVIDYALAYA  
Address  Dr VJD Gramin ayurved mahavidyalaya Near renuka mata mandir Patur tal Patur district akola State Maharastra Country India Pincode 444501 
Type of Sponsor  Research institution and hospital 
 
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 Aniket Pruthviraj Pawar   Dr VJD Gramin Ayurved Mahavidyalaya Patur  Dr VJD Gramin Ayurved Mahavidyalaya Near renuka mata mandir Patur Tal Patur District Akola State Maharashtra Country India Pincode 444501
Akola
MAHARASHTRA 
9769111276

aniket.pawar992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Dr VJD GRAMIN AYURVED MAHAVIDYALAYA PATUR AKOLA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mushalyadi yoga , Reference: Bhaishajya Ratnawali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Vyoshadi churna , Reference: Bhaishajya Ratnawali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having Arsha [1st and 2nd degree] will be selected
2.Patient of age between 20 to 60 years will be taken
3.Patients with hb Greater than 8mg/dl
4.Selection of patient will be done irrespective of
sex, socioeconomic class , religion. 
 
ExclusionCriteria 
Details  1.Known case of 3
rd and 4th degree haemorrhoids.
2.Patients with hb less than 8mg/dl
3. Pregnancy
4.Known case of DM,HIV, HbsAg positive.
5.Patients below 20 and above 60 years will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like
1.Raktastrava [Amount of bleeding per anum]
2. Malavshthambha[Constipation]will be decreased and Control over Arsha with special reference to 1st and 2nd degree internal heamorriods  
07 Days,14 Days,21Days after starting treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Symptoms of Arsha  18 months 
 
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 Applicable 
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   The main aim of Ayurveda is the prevention as well as cure for
every diseases
. Ayurveda has mentioned the eight disciplines which
is called ‘Ashtanga Ayurveda’ in which Shalyatantra Chikitsa is
preferably first type of treatment in Sushrut samhita.
Arsha or Haemorrhoids are progressively increasing in the society. It
is manifested due to multifold factors viz. disturbed life style or daily
routines, improper or irregular diet intake, prolonged standing or
sitting, faulty habits of defecation etc. which results in derangement
of Jatharagni leading to vitiation of Tridosha, mainly Vata Dosha3
.
These all vitiated Doshas get localized in Guda Vali sthana and
Pradhana Dhamani4 which further vitiates Twaka, Mansa, and Meda
Dhatus which leads to Annavaha Strotodushti which develops Arsha5
.
Haemorrhoids is a disorder which is embarrassing to the patient. The
perianal skin is one of the most pain sensitive region present in the
body due to rich nerve endings. This develops discomfort to the
patient6
.
 Arsha is being described by all the Samhita & Classics of
Ayurveda. Acharya Sushruta has mentioned Arsha disorder in the
‘AshtauMahagada’
7
. Arsha occurs in Guda region, which is also
described as Marma8
, and it is well known for its chronicity and
difficult management.
 In today’s era Arsha is one of the most common and
distressing disease due to the Sedentary life style and irregular
dietary habits. Rakta Arshas is one of the bheda of Ardra Arshas. Per
rectal bleeding is the chief complaint in 1st degree internal
haemorrhoid.
Acharya Sushruta has mentioned Chikitsa of Arsha which
includes Tikta Rasatmaka Dravyas are given to the patients for
Agnisandeepan, haemostasis & Pachana of Doshas9
.
 Arsha can be correlated with Haemorrhoids in Modern
science. Haemorrhoids defined as dilated plexus of superior
haemorrhoidal veins in relation to anal canal10
.
From all types of Arshas, Stravi Arsha can leads to the life threatening
complications if not treated during early stage. Bleeding through pile
mass can leads to Anaemia or any other serious complications.
Stoppage of bleeding is primary goal in the Rakta Arsha (bleeding
piles). Bheshaja Chikitsa is more effective in early stages of Rakta
Arsha and it has greatest advantage of wider acceptability by the
patient

 
Close