| CTRI Number |
CTRI/2025/06/088357 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate efficacy of external application of Champakadi Agad Lepa in Agantuja Vrana. |
|
Scientific Title of Study
|
A randomized controlled study to evaluate the efficacy of external application of Champakadi Agad Lepa in the management of Agantuja 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 Saurabh Lipane |
| Designation |
M.D.(Agadtantra) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D. No 4 Agadtantra department ground floor sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9028627621 |
| Fax |
|
| Email |
saurabhlipane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manohar Khankhane |
| Designation |
Head of department |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
OPD No. 4 Agaadtantra department ground floor sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888763651 |
| Fax |
|
| Email |
khankhanemanohar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Lipane |
| Designation |
M.D.(Agadtantra) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D. No 4 Agadtantra department ground floor sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9028627621 |
| Fax |
|
| Email |
saurabhlipane@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved mahavidyalaya OPD No. 4 Agadtantra department ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune maharashtra india 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Saurabh Jitendra Lipane |
| Address |
OPD No. 4 Agaadtantra department ground floor Sane guruji Arogya Kendra Malwadi Hadapsar Pune maharashtra india 411028 |
| 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 Saurabh Jitendra Lipane |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
OPD No. 4 Agaadtantra department ground floor Sane guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
9028627621
saurabhlipane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T889||Complication of surgical and medical care, unspecified. Ayurveda Condition: AGANTUJAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | povidone iodine ointment | povidone iodine solution will be used to give proper wound wash and application of povidone iodine ointment over wound properly as per requirement so that it will cover the whole wound. cover the wound with sterile guaze pad of adequate size every 3rd day to 15th day | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushrut chikitsasthan 1/14, Ashtang hriday uttartantra 26/7, Procedure details: Champakadi agad lepa will be applied over wound properly as per required so that it will cover the whole wound. cover the wound with sterile quaze pad of adequate size every 3rd day to 15th day)
(1) Medicine Name: Champakadi Agad , Reference: Ashtang hriday uttartantra 37/71, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Area of wound 1x1cm to 8x8cm,
Patient irrespective of gender, economic status, caste,Patient having Vrana like Ghrishta Vrana (abrasion wound) |
|
| ExclusionCriteria |
| Details |
K/C/O HIV, HbsAg, Hep.B, Immuno-compromised patients, Burns, Scalds, Chemical burns wounds,
Pregnant women, Post operative wound, Gangrenous wound, Bed sores, Varicose ulcer |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Ropana effect of Champakadi Agad Lepa in Agantuja Vrana |
at the end of 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate efficacy of Champakadi Agad Lepa in Agantuja Vrana |
at the end of 15th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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 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
|
Nowadays management of wounds are significantly problematic for all healthcare systems. healing of wounds has been a challenging in anciant as well as in todays era. management of agaantuja vrana in ayurveda given by various acharyas with various ayurvedic formulations for fast healing of vrana. one of that is champakadi agad lepa mentioned in ashtang hriday uttartantra 37/71 , which contains drugs which has properties like twachya, varnya, raktastambhak, shoolaghna,shothaghna,daha shamak, raktaprasadak. these properties helpful in vrana sthapana.by using this champakadi agad lepa in agantuja vrana by extenally application on wound surface in required quantity on 0th day and repeated dressing on every 3rd day for 15th day. the outcome of this study validate the therapeutic potential of champakadi agad lepa, encouraging its broader clinical use. |