| CTRI Number |
CTRI/2025/05/086884 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Ayurvedic medicine on wound healing |
|
Scientific Title of Study
|
An open labelled comparitive two arm prospective clinical study to eveluate the efficacy of nimbpatradi lep in 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 |
Shrutika Sandeep Kate |
| Designation |
3rd year BAMS(UG) |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala Ganeshwadi panchavati nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9529119973 |
| Fax |
|
| Email |
shrutika8622@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Pathak |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405369727 |
| Fax |
|
| Email |
drsantoshsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Pathak |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405369727 |
| Fax |
|
| Email |
drsantoshsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Maharashtra University of Health Sciences,Nashik under the scheme of STRG |
| Address |
Maharashtra University of Health Sciences, Dindori road,Mhasrul,Nashik 422004 |
| Type of Sponsor |
Other [Health University] |
|
|
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 Santosh Pathak |
Arogyashala Rugnalaya |
OPD 6 Shalya opd Arogyashala rugnalaya ganeshwadi panchavati
Nashik
MAHARASHTRA |
7767939759
drsantoshsp@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbapatradi lep, Reference: sushrut chikitsasthan 1 shloka number 68 69 , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: No, Route: -, Dosage Form: Kalka/ Paste , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine | Betadine i.e. povidone iodine is used for cleaning and dressing of wound. It is an effective and useful germicide. It is widely used for dressing in wounds |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients Of age 18 to 60.
2) Patients who will give consent for study .
3) Both Male and female
4) Patient with all types of Dushta vrana with maximum history of 1 month
5) Patient having clinical feature of Nija /Agantuj Dushta vrana i.e. foul smell, pus discharge ,pain, burning sensation will be selected for study
6) Wound less than or equal to 30 cm2 area.
7) Ulcer with depth = muscle deep
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from systemic disease like uncontrolled Diabetes mellitus, Tuberculosis , CKD, Severe Anemia , Malnutrition were excluded from the study.
2) Patient suffering from grave condition likes malignant ulcer and other severe illness like HIV were excluded.
3) Wound Size greater than 30cm2 or Depth more than 1 cm
4) Following ulcer will be excluded
Bone deep ulcer (Depth more than 1 cm )
Compound fractures
Ischemic Ulcer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nimbapatradi lep has wound healing potential as equal to betadine |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nimbapatradi lep improves parameters like discharge foul smell etc in vrana |
10 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/05/2025 |
| 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
|
Ayurveda is a holistic
science of life, health & cure committed to healing wholeness. Shalyatantra is one of the
important branches of Ayurveda in which surgical and parasurgical techniques have been
described for management
of various surgical diseases.
In medical practice, healing
of wound (vrana) in a short period of time is very important factor. Growing
civilization and today lifestyle we come across many such patients with
varieties of wound. Sometimes healing will not happen in a healthy way at wound
site and it takes lots of time for skin to regain its natural state. Even
though healing of wound is a natural process of body, the vrana should be
protected from doshadushti and from various infections which may hamper the
natural rate of healing of wound. Vrana is the most important and widely
described chapter of ShalyaTantra by Acharya Sushruta. Sushruta is known for
miscellaneous in surgical
procedures. He has described
Vrana in a very precise manner.
As the sciences advanced,
newer therapies are tried out to boost up the recovery process but still the
older remedies lead the race. Acharya Sushruta explained vrana in detail in his
classical book Sushruta Samhita. As concourse of wound healing procedures
described by sushruta samhita still holds its place. Acharya Sushruta explain
various kalpa for management of vrana. So in this study, we are highlighting
one of the kalpana from Sushruta samhita.
Now a days, Betadine i.e.
povidone iodine is used for cleaning and dressing of wound. It is an effective
and useful germicide. It is widely used for dressing in wounds. However its
frequent use is contraindicated because of it’s insolubility and its staining
and irritable properties.
Ayurvedic texts grant us the
opportunity to treat wounds (Vrana) with cost effective medication instead of
surgical procedure. Delayed healing in wound in main complain of patient of
vrana .As mentioned in Ayurvedic Samhitas ,Vrana is caused by both Nija &
Agantujhetu. ‘ Nimbpatradi Lep’ is an
ideal formulation which shows Shodhan and
Ropana effect causes wound healing . Hence it was decided to take up
this subject. |