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CTRI Number  CTRI/2024/07/071668 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Study Effectiveness Of Madhu-Sarpi In The Management Of Post Operative Ano-Rectal Wound (sadyovrana) 
Scientific Title of Study   A Randomized Controlled Clinical Trial To Study The Effect Of Madhu-Sarpi As Local Application In Post Opertive Ano-Rectal Wounds 
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 Suyash Ramdas Zagade 
Designation  Pg scholar 
Affiliation  SMBT ayurved medical college and hospital  
Address  SMBT ayurved medical college and hospital shalyatantra department dhamangaon igatpuri Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  8976686634  
Fax    
Email  suyashzagade@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr datta bhikan kumawat  
Designation  Professor & Guide 
Affiliation  Smbt ayurved medical college and hospital  
Address  SMBT ayurved medical college and hospital shalyatantra department dhamangaon igatpuri Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  9049059799  
Fax    
Email  drdkumawat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suyash Ramdas Zagade 
Designation  Pg scholar 
Affiliation  SMBT ayurved medical college and hospital  
Address  SMBT ayurved medical college and hospital shalyatantra department dhamangaon igatpuri Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  8976686634  
Fax    
Email  suyashzagade@gmail.com  
 
Source of Monetary or Material Support  
Department of shalyatantra Smbt ayurved medical college and hospital Nashik Maharashtra india 422403 
 
Primary Sponsor  
Name  Dr Suyash Ramdas Zagade  
Address  Smbt ayurved medical college and hospital shalyatantra department dhamangaon igatpuri Nashik 422403 
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 SUYASH RAMDAS ZAGADE   SMBT AYURVED MEDICAL COLLEGE AND HOSPITAL   Department of shalyatantra ,Shalyatantra,OPD NO. 3
Nashik
MAHARASHTRA 
8976686634

suyashzagade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Smbt Ayurved Mahavidyalay Dhamangaon Igatpuri Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: SADYOVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-avagAhasvedaH, अवगाहस्वेदः (Procedure Reference: Charak sutrasthan 14/45-47, Procedure details: Avagaha svedaha or sitz bath used in ano rectal disease Three times procedure will be done With adjuvant treatment Sitting in hot water tub submerging the affected region)
2Intervention ArmDrugClassical(1) Medicine Name: Madhu sarpi, Reference: Sushrut chikitsa-sthan DvivarniyachikitsaAdhyaya, 1/129, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 01(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: Adjuvant treatment 3 days antibiotics Sitz bath(avagaha sweda) Syp.cremaffin Analgesic (sos)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.patients with ano-rectal disease and undergoing surgery and who are fit for Surgery.
2.Patients fulfilling the diagnostic criteria and undergoing Surgery 3.patients who will give consent for the use of drug
4. Patients having post operative anorectal wound  
 
ExclusionCriteria 
Details  1. Patients with multiple Fistula-in-ano,Anal prolapse,Anal cancer
2. Immuno compromised patients
3. Subjects on Anti-depressant and Anti- psychotic Drugs.
4. K/C/O : Diabetes and hypertension,Mentally retarded
subjects 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Shool And Daha Assessment And Ropan Effect In Post-Operative Ano-Rectal Wound After Application Of Madhu-Sarpi In 10 Days Of Post Operative Procedure   18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Vrana (wound) Will Be Studied During Intervention Period.
Healing Stages And Time For Healing Process Of Wound Will Be Observed 
18 Months 
 
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 
Date of First Enrollment (India)   10/08/2024 
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  
Perianal disease presented chiefly as hemorrhoids , fissures and fistula/abscess .In most of condition surgical intervention is required. Post operative pain and burning sensation is a frequent complaint in patient undergone surgery. So management of these wounds needs special attention itself. Post operative wound care of ano rectal surgeries is different from that of other wound due to following reasons;
1. Fecal material contaminates the wound, so frequent dressing is required to keep the wound clean.
2. Wound being on dependent part causes pain and burning sensation which makes it difficult for patient to walk and sit.
In ano rectal surgeries wound, pain and burning sensation are the most common symptom present locally. Acharya Sushrut explained MADHU-SARPI in Chikitsa Sthan
 After any anorectal surgery patient always complains about pain at operated site at least for 2-3 days. In pain and burning sensation management post operatively, Surgeons do prefer using OPOIDS and NSAIDS both of these have their own side effects like gastric pain, mucosal erosion/ulceration etc. so ancient science gives prolong pain relief with wound healing medicines
Also,
1.Gud is marma sthan,which is one of most important tri-marma according to ayurveda
2.In other wound we are able to rest certain site orcover it but in ano rectal wounds anal region is in continuous working mode
3.other wounds are generally covered either with suture or with dressing
4.As the area is continuosly in contact with faecal matter there are high chances wound’s gettng infected
5.Nerve supply is most prominent in anal region
So the drug selected Madhu-Sarpi is having properties of analgesic , anti-inflammatory, wound healing
 
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