| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | avagAhasvedaH, अवगाहसà¥à¤µà¥‡à¤¦à¤ƒ | (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)
| | 2 | Intervention Arm | Drug | Classical | | (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 |