| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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 |