FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071387 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
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   A clinical study to see the effect of PARNABEEJA oil ointment and sesam oil Ointment in healed wound 
Scientific Title of Study   RANDOMIZED CONTROLLED CLINICAL STUDY OF PARNABEEJA SIDDHA TAIL MALAHAR TOPICAL APPLICATION IN COMPARISON WITH TILA TAIL IN SHUDDHA VRANA 
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 Anand Kumar Shyambali Prajapati 
Designation  PG SCHOLAR 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  8286214707  
Fax    
Email  anandpro87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin D Nalawade 
Designation  Assistant Professor  
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9822522905  
Fax    
Email  Nalawadenitin54@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anand Kumar Shyambali Prajapati 
Designation  PG SCHOLAR  
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  8286214707  
Fax    
Email  anandpro87@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurved Hospital, Rasta Peth, Pune 411011  
 
Primary Sponsor  
Name  Tilak ayurved mahavidyalaya pune 
Address  Tilak Ayurved Mahavidyalaya, Department of Shalyatantra, 2nd floor, Rasta peth Pune 411011 Maharashtra  
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 Anand Kumar Shyambali Prajapati   Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Cheritable Ayurved Hospital   OPD no7 Dept of Shalyatantra pune
Pune
MAHARASHTRA 
8286214707

anandpro87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Parnabeeja sidha tail, Reference: Dravyaguna vijnana vol 2, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Tila tail malahar, Reference: Madhav nidan tailavarga 18, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patient ready to give written consent will be selected.
Fresh incised wounds, lacerated wounds within24 hours will be selected.
Surgical wound eg.post op . circumcision wound 
 
ExclusionCriteria 
Details  Venous,tubercular,ischemic, malignant ulcers
Infected wounds
Diabetic wounds having discharge or slough
Patient suffering from HIV,HbsAg 
 
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 
Darshana Pariksha- akruti,vrana srav,vrana tala,Rana gandha,  15days 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of akruti,vranastrav, vranatala, vranagandha  15days 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 2/ 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="0"
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   Today wound is basic problem in surgical practice Surgeon deals with inflammation & problem in
healing in any surgical disorder. Even though Vrana is a natural process of healing it should be
protected from dosha dushti from various microorganism, which may affect the vrana and delay the
normal healing process. Wound has different aspect for healing process If is left untreated can
leads to complication. So we are looking for effective management. Dushta Vrana (Infected wound)
is a common problem faced in surgical practice. The presence of Dushta Vrana worsens the
condition of the patient with different complicationsand maybecome fatal. Wound healingisanatural
process, but factors like slough, infection and foreign bodies, affect the normal process of healing. A
healthy wound in anormal body heals earlier with a minimum scar as compared to a contaminated
wound. Therefore in the present concept, all efforts are directed to keep the wound clean during the
various stages of its healing process. Wound is a physical injury to any of the tissues in the body
that results in a break in the continuity of soft parts of body structures[8]. A process of healing of
wound is a normal biological response to the injury that occurs naturally, as long as the local care is
adequate. The normal phases of wound healing-reaction, regeneration, and remodeling take place
without any difficulty, if wound is debrided properly of non-viable tissue and repaired it in a physiological manner. Acharya Sushruta has given much emphasis on Vaikruthapaham. Hence
good wound healing with minimal or no scar formation is the prime motto.Sushruta, Charaka,
Vaghbhata, Madhavakar and Sharangdhara have clearly mentioned that the Lakshanas of Dushta
Vrana as foul smelling, continuously flowing pus discharge along with blood filled cavities, which
can be correlated to non-healing or contaminated wound. Infected wounds mostly require surgical
debridement to stabilize the patient as well as to promote healing process, longer hospitalization,
and surgery with use of anaesthesia drug, wound care and also other expenses
 
Close