| CTRI Number |
CTRI/2025/02/081208 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Ayurvedic Drug In Treatment Of Burn. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Triphala Mashi Lepa In Agnidagdha 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 Gouri Vijay Mane |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329100920 |
| Fax |
|
| Email |
realgourimane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Devidas Pawar |
| Designation |
Associate Professor |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9822285836 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gouri Vijay Mane |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329100920 |
| Fax |
|
| Email |
realgourimane@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt
Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr.Gouri Vijay Mane. |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri,
Maharashtra, India-415722. |
| 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 Gouri Vijay Mane |
Parshuram Hospital & Research Center |
Shalyatantra OPD , Ghanekhunt Lote,Khed Ratnagiri MAHARASHTRA
Ratnagiri
MAHARASHTRA |
8329100920
realgourimane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved mahavidyalaya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T310||Burns involving less than 10% of body surface. Ayurveda Condition: AGNIDAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Silver sulfadiazide | Silver sulfadiazide application according to the burn site daily once for 14 days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bruhat nighantu ratnakar, Procedure details: Triphala mashi with tila taila lepa application according to size of burn daily once for 14 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients Age between 18 to 60 years.
2) Patients irrespective of sex, religion, occupation etc
3) Patients with 1st and 2nd degree superficial burn.
4) Patients having up to 5%TBSA (Total body surface area)burn.
5) Patients having wounds on extremities and trunk only.
6) Agnidagdh vrana due to heat including dry and moist.
7) Patients who are willing for trial &ready to give informed consent. |
|
| ExclusionCriteria |
| Details |
1) Age group less than 18 years and more than 60 yrs.
2) Patients having more than 5% TBSA (Total body surface area)burn.
3) Patients with 2nd degree deep burn and above that .
4) Known case of AIDS, Uncontrolled DM, Hepatitis B., TB and
immunocompromised people.
5) Electrical, Chemical, Frost and Radiation burn.
6) Taxemia , Septicemia.
7) Head, Neck, Genital Organs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Ropan effect of Triphala Mashi Lepa in Agnidagdh vrana. |
14 days study with follow up on 5th,10th,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Literature study of Agnidagdh vrana from Ayurvedic & modern
texts.
2) Literature study of Triphala churna from Ayurvedic & modern
texts.
3) Literature study of Mashi Kalpana from various Ayurvedic texts.
4) Significance of Ropan activity in Agnidagdh vrana as per Ayurved
and modern texts. |
14 days study with follow up on 5th,10th,15th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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="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
|
Title - A Randomised Controlled Clinical Trial To Evaluate The Efficacy of Triphala Mashi Lepa In Agnidagdh Vrana. Null Hypothesis - Triphala Mashi Lepa is not effective in Agnidagdh vrana.
Alternative Hypothesis -Triphala Mashi Lepa is effective in Agnidagdh vrana.
Study design - Simple Randomized Controlled Clinical Trial.
Inclusive Criteria - 1) Patients Age between 18 to 60 years. 2) Patients irrespective of sex, religion, occupation etc 3) Patients with 1st and 2nd degree superficial burn. 4) Patients having up to 5%TBSA (Total body surface area)burn. 5) Patients having wounds on extremities and trunk only. 6) Agnidagdh vrana due to heat including dry and moist. 7) Patients who are willing for trial &ready to give informed consent.
Exclusive Criteria -1) Age group less than 18 years and more than 60 yrs. 2) Patients having more than 5% TBSA (Total body surface area)burn. 3) Patients with 2nd degree deep burn and above that . 4) Known case of AIDS, Uncontrolled DM, Hepatitis B., TB and immunocompromised people. 5) Electrical, Chemical, Frost and Radiation burn. 6) Taxemia , Septicemia. 7) Head, Neck, Genital Organs.
Sample size - Total 50 (25 for each group).
Patient coming in OPD and IPD of Shalyatantra department of our hospital with complaints of thermal burn .Simple randomized sampling ( Lottery Method) .
Group A - Triphala Mashi Lepa .
Group B - Silver Sulphadiazine local application.
Total duration of drug administration is 14 days.The mode of drug administration will be by local application.
Follow up - Follow up will be done on 5th,10th,15th day.
Result - Result will be drawn as per assessment criteria and statistical analysis.
|