| CTRI Number |
CTRI/2025/12/099023 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effectiveness of Manjishtadi Taila in treating first and second degree burns.
|
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Manjishtadi Tail in Durdagdha with special reference to first and second degree burn. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Vaijnath Chavan |
| Designation |
M.S Scholar Shalyatantra Samanya |
| Affiliation |
Shree Saptashrungi ayurvedic mahavidyalaya |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
07038497623 |
| Fax |
|
| Email |
chavanganesh105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor Shalyatantra Department |
| Affiliation |
Shree Saptashrungi ayurvedic mahavidyalaya |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Vaijnath Chavan |
| Designation |
M.S Scholar Shalyatantra Samanya |
| Affiliation |
Shree Saptashrungi ayurvedic mahavidyalaya |
| Address |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
07038497623 |
| Fax |
|
| Email |
chavanganesh105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra Samanya OPD no. 3 Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya OPD no. 3 Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia |
| 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 Ganesh Chavan |
Department of Shalyatantra Samanya Shree saptashrungi Ayurved Mahavidyalaya and hospital |
Department of Shalyatantra Samanya OPD no. 3 Shree saptashrungi Ayurved Mahavidyalaya Kamal Nagar Hirawadi Panchvati Nashik Maharashtra 422003I ndia
Nashik
MAHARASHTRA |
07038497623
chavanganesh105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptashrungi Ayurved Mahavidyalaya Nashik Panchavati Maharashtra422003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Silver sulphadiazine | Local application over burned area | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi taila, Reference: Bahaishajya ratnavali 48/20, Route: Topical, Dosage Form: Taila, Dose: 10(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi taila, Reference: Bahaishajya ratnavali 48/20, Route: Topical, Dosage Form: Taila, Dose: 10(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinical assessment for durdagdha associated with burn |
|
| ExclusionCriteria |
| Details |
1.Third Degree Burn
2.fourth degree Burn
3.Patient with Any comorbidities
4. Burn over Genital Area
5. Burn over facial parts |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Controlled clinical study to assess the efficacy of Manjistadi tail in the
management of durdagdha w.s.r to 1° and 2° burn.qq |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
12 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
14/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Randomized controlled clinical trial to evaluate efficacy of manjishthadi taila in Durdagdha with special reference to first and second degree Burn Primary Objective -Controlled clinicalstudy to assess efficacy of Manjishthadi taila in the management of Durdagdha w.r.t First degree second degree Burn
Secondary Objective - 1. To study the first and second degree Burn and Durdagdha as per ayurvedic and modern conect 2. To study about Manjishta
STUDY DESIGN - Randomized controlled clinical trial Group A( trial group) - Manjishthadi taila Group B (control Group)- 1 percentage Silver sulphadiazine Assessment 0,7,14,21 th Day Sample size- 62 , each group 31
Data analysis Data will be analysed using appropriate statistical methods to compare the effectiveness of intervention on the primary and secondary outcomes.
Ethical Consideration - The study will be conducted in accordance with Ethical Guidelines and with informed consent from participants.
|