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CTRI Number  CTRI/2024/03/063805 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
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   Study the effect of ayurvedic tablet in piles 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in Arsha with special reference to 1st and 2nd Degree Internal 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  Dr Bhausaheb Prataprao Suryawanshi 
Designation  PG scholar 
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwai Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8999220889  
Fax    
Email  suryawanshi735@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Santosh Pathak 
Designation  Assistant Professor And Guide  
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwai Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  7767939759  
Fax    
Email  drsantoshsp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Santosh Pathak 
Designation  Assistant Professor And Guide  
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwai Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  7767939759  
Fax    
Email  drsantoshsp@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 422003 
 
Primary Sponsor  
Name  Vd Bhausaheb Prataprao Suryawanshi 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Panchavati Nashik 
Type of Sponsor  Other [Self] 
 
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 Bhausaheb Prataprao Suryawanshi  Arogyashala Rugnalaya Nashik  Ayurved Seva Sangh Ganeshwai Panchavati Nashik
Nashik
MAHARASHTRA 		 8999220889

suryawanshi735@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jatiphaladi Vati, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Pilonash, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patient Diagnosed with 1st and 2nd degree of Internal Haemorrhoids of both sexes.
2)Patients having following Clinical features of Arsha.
a)Agnimandya
b)Saraktamala Pravrutti
c)Gudashool
d)Malavshtambh
e)Gudakandu
3)Patient willing to participate with informed written consent.
 
 
ExclusionCriteria 
Details  1.Pregnant women and lactating mother
2.Severe anaemic patient
3.Patient having systemic disorders like portal hypertension,liver cirrhosis
4.Patient having immunocompromise disordres
5.Bledding disorders like haemophillia and purpura. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in pain in ano.
Stopage of per rectal bleeding
Anal itching  		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms like bleeding per rectum,itching and pain at anal region  28 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/03/2024 
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="2"
Months="0"
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    Haemorrhoid is a one of the anorectal disorder which is commonly seen in the society. According to Modern Science ,Arsha is correlate with Haemorrhoid .Haemorrhoid is a varicosity and Dilatation of haemorrhoidal veins of anal canal .As Per Ayurveda The Disease ’Arsha ’ comes under the heading of Maharogas .Because it dushchikitsy,,dirghakalanubandhi and involves the Marma.Arshas is a clinical condition in which structural derangement take place. As per ayurveda, the vitated doshas (vatta,pitta ,kapha )contaminate the twak,mansa,rakta,meda and hampers the function of apan vayu , causes Mansa ankuras at the anal opening .Heamorrhoids is very common ano rectal disease.About 50% to 60% of the people will have heamorrhoid at same point in their lives.Haemorrhoids have conservative as well as surgical treatment as like Cryosurgery,Dilatation, Haemorrhoidectomy, Heamo rrhoid stapling , Rubber band ligation and Sclerotherapy, but not all of them have been uniformly successful. As compared to conservative treatment surgical procedure are expensive, post opeartive pain is unbearable.so patient are not willing for surgical intervention..In Ayurveda Bhaishajakarma is the first line of treatment because there is no fear of complication,bleeding and putrification in comparison of others.Ayurveda has mentioned many herbal formulation of arshas. Hence a randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in arsha with special reference to 1st and 2nd degree internal haemorrhoids study was undertaken.
    In this study 80 patients will be randomly selected showing signs and symptoms of internal haemorrhoids and are randomied into 2 groups.Trail group will be treated with the standared treatment with Jatiphaladi Vati while control group will be treated with ayurvedic prepration Tab.Pilonash. In clinical study patient will be examined according to subjective criteria which includes 1.Gudgatraktastrav (Per rectum bleeding),2.Gud Kandu (Anal itching),3.Gudshool (Pain at anal region)by Visual Analogue Scale and objective Criteria Including 1.Degree Of Pile, 2.Malavshtambha(Constipation), by Victoria Bowel Perfomance Scale 3.Laboratory Blood Chemistry Tests as under 1.CBC,2.BT,3.CT,4.Stool examination for occult blood if required.The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trail.
 
 
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