| CTRI Number |
CTRI/2025/06/088866 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Efficacy Of Punarnawadi Lepa In The Management Of Aamavstha Of Vranashopha With Special Reference To Early Stage Of Cellulitis |
|
Scientific Title of Study
|
Randomized clinical controlled study to evaluate the efficacy of Punarnawadi lepa
in the manegement of amavastha of vranashopha with special reference to early
stage of cellulitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankush Rudraji Suryavanshi |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9834366094 |
| Fax |
|
| Email |
ankushsuryawanshi1753@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramachandra Shedge |
| Designation |
Guide and HOD Professor In Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist-Sangli,415409 Maharashtra India
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist-Sangli 415409, Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankush Rudraji Suryavanshi |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital, PG Institute And Research Centre Urun Islampur Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9834366094 |
| Fax |
|
| Email |
ankushsuryawanshi1753@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Instutue And Research Centre Urun Islampur dist sangli , maharashtra ,INDIA 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Ankush Rudraji Suryavanshi |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 415409 Maharashtra India |
| 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 Ankush Rudraji Suryavanshi |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli
Sangli
MAHARASHTRA |
9834366094
ankushsuryawanshi1753@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic medical college and post graduate research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L039||Cellulitis and acute lymphangitis,unspecified. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: yogratnakar shothdikar adhyay 1 /133 , Procedure details: Amavasatha will be clean be NS , punarnawadi lepa will be apply , dressing will be done )
(1) Medicine Name: punarnawadi lepa, Reference: yogratnakar shothdikar adhyay 1 /133 , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | mgso4 dressing | amavastha of vranashofa will be clean with NS, MGSO4 dressing will be apply |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between age group of 18 to 60 years will be selected irrespective of gender, occupation and socioeconomic status.
2. Vrana within size upto 100 sq.cm.
3.Patient having sign & symptoms of amavastha of vranashopha.
|
|
| ExclusionCriteria |
| Details |
1.Patients below age group of 18 and above age group of 60 years.
2. Patients with systemic disease. eg- diabetes mellitus hypertension etc.
3. Snake Bite.
4. Patients with Severe anemia.
5. Patients suffering from bleeding disorders will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Punarnawadi lepa application in the management of
Amavastha of vranashopha with special referance to early stage of cellulitis. |
Application Of Punarnawadi Lepa On 0th,1st,2nd,3rd,4th,5th,6th Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail the literature about vranashopha according to Ayurvedic aspect
2.To study in detail the literature about vranashopha according to Modern
aspect.
3.To prepare punarnawadi lepa .
|
Application Of Punarnawadi Lepa On 0th,1st,2nd,3rd,4th,5th,6th Day. Folloup On 10th And 15th Day. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/06/2025 |
| 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="0"
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
|
The aim of she study is to study the efficacy of punarnawadi lepa application in the management of amavastha of vranashopha with special reference to early stage of cellulitis. In this present era management of amavastha of vranashopha is necessary . In this punarnawadi lepa containing sthothahara, vedanasthapaka, vranashodhak, vranaropak properties which is effective in early stage of amavastha. The punarnavadi lepa mentioned in yogaratnakara shothadhikara adhyaya indicated for vrana and vrana shotha as bhaishaj chikitsa. Hence this formulation is selected for the management of vranashopha (CELLULITIS). The advantage of this formulation is that the method of prepration is very simple and it can be used easily . The age group selected for the study is 18 to 60 yrs. Sample size selection will be 35-35 each for trial and control group. Ayurvedic formulation will be given for continue 7 day followed by followup on 10th and 15th day. Evaluation of both group using statistical tool will be done and conclusion will be made. |