| CTRI Number |
CTRI/2026/02/104068 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effect of Pracchankarma in the Treatment of Cellulitis (Vranashotha) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Assess the Effect of Pracchankarma in Management of Vranashotha W.S.R. to Cellulitis |
| 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 Pravin Suresh Tale |
| Designation |
PG Scholar |
| Affiliation |
DR G D Pol Foundation Y M T Ayurvedic Medical College and Hospital |
| Address |
Dr G D Pol Foundation Y M T Ayurved College and Hospital, 3rd Floor, Shalyatantra Department, Sector 4, Kharghar, Navi Mumbai – 4102100
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8788825790 |
| Fax |
|
| Email |
pravintale2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Professor, PG Guide |
| Affiliation |
Dr G D Pol Foundation Y M T Ayurvedic College and Hospital |
| Address |
Dr G D Pol Foundation Y M T Ayurved College and Hospital, 3rd Floor, Shalyatantra Department, Sector 4, Kharghar, Navi Mumbai – 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Suresh Tale |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation Y M T Ayurvedic College and Hospital |
| Address |
Dr G D Pol Foundation Y M T Ayurved College and Hospital, 3rd Floor, Shalyatantra Department, Sector 4, Kharghar, Navi Mumbai – 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8788825790 |
| Fax |
|
| Email |
pravintale2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation, Y M T Ayurvedic Medical College And Hospital, Sector- 4, Kharghar , Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
DR PRAVIN SURESH TALE |
| Address |
Dr G D Pol Foundation Y M T Ayurved College and Hospital, 3rd Floor, Shalyatantra Department, Sector 4, Kharghar, Navi Mumbai – 410210 |
| 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 Pravin Suresh Tale |
Dr G D Pol Foundation Y M T Ayurvedic College and Hospital |
Dr G D Pol Foundation Y M T Ayurvedic College and Hospital , 3rd Floor, Shalyatntra Department, Sector 4 kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
08788825790
pravintale2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D pol foundation YMT ayurvedic medical college and charitable hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | PRACCHANKARMA | (Procedure Reference: AH Su 26/53 ,Su. Chi.1/28-29-30 , Procedure details: • Ask patient to lie down comfortably on either side of body depending on affected part.
• Demarcation of site of Prachhankarma
• Prior to the procedure, the affected area is cleansed with Betadine scrub & then with spirit to ensure asepsis.
• The affected area was disinfected with the help of 10%betadine solution.
• Using a scalpel no. 23 multiple superficial parallel were made to facilitate the drainage of extracellular fluid in the inflamed area.
• The exudate was gently wiped with gauze & a pressure roller-bandage was applied.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Magnesium Sulphate dressing | Dissolve 20 grams of magnesium sulfate in 100 ml of glycerine.
Stir until a uniform, slightly thick solution forms.
• Soak roller bandage or gauze in the prepared glycerine–magnesium sulfate solution.
• Wrap or apply the soaked bandage over the inflamed or edematous area of the limb.
• Apply a light compression bandage over the soaked material to secure it in place.
• Ensure the affected limb is elevated to promote venous return and reduce swelling.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Vranashotha cellulitis Amaavastha and Pachyamana Avastha
Age group 18 to 60 years
Gender Male And Female
Patients Fit for Raktamokshana
|
|
| ExclusionCriteria |
| Details |
Immuno compromised patients
HB Less than 9 gm percent
Uncontrolled Diabetes
Pakwaa Vranashotha
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Effect of Prachhankarma in the Management of Vranashotha (Cellulitis) and Compare its Effect with Magnesium Sulphate Dressing |
0 3rd & 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Magnesium Sulphate Dressing in the management of Vranashotha (Cellulitis)
|
0 3rd & 7th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
09/03/2026 |
| 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
|
The Present Study is a PG Thesis Topic by PG Scholar – Dr Pravin Suresh Tale and Guide Name – Dr Sanjeev Yadav.
Title – A Randomized Controlled Clinical Trial to Assess the Effect of Pracchankarma in Management of Vranashotha W.S.R. to Cellulitis.
Study According to Inclusion and Exclusion Criteria, Group A – 21 Patients and Group B – 21 Patients will be Selected. Group A (Intervention) will be Given Prachhankarma for 7 Days. Group B (Control) will be Given Magnesium Sulphate Dressing for 7 Days. Total Duration of Study is 1 Year 6 Months. |