| CTRI Number |
CTRI/2024/11/076276 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to see the effect of some ayurvedic formulation in the treatment of vranashopha(cellulitis) |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study to evaluate efficacy of Punarnava Kwath with Punarnava Ointment and Glycerine MgSo4 Dressing in Vranashopha With special reference 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 |
DrGovind Dnyanoba Gutte |
| Designation |
Ms Scolar Shalyatantra(Ayurveda) |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8208183957 |
| Fax |
|
| Email |
govindgutte20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MD PhD Associate Professor |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MD PhD Associate Professor |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane guruji Aarogya Kendra Mal Hadapsar pune 411028 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Sane guruji Aarogya Kendra Malwadi Hadapsar pune |
| Address |
opd No 3 Shalyatantra Department Sane guruji Arogya kendra Malwadi Hadapsar Pune 411028 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Govind Dnyanoba Gutte |
Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8208183957
govindgutte20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya hadapsar Pune INSTITUTIONAL ETHICAL COMMITTEE |
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 | Comparator Arm (Non Ayurveda) | | - | Glycerine mgso4 | Glycerine mgso4 route-topical Dosage-Malahara/ointment Frequency-OD Duration 7 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnava Kwath, Reference: Sharandhar Samhita, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Medicine Name: punarnava Ointment, Reference: Bhavprakash nighantu, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: punarnava is Shothaghna. | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punanrnava Ointment, Reference: Sharandhar Samhita, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Punarnava have shofaghn properties and also mutral dravya |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Aamawastha and pachyaman aavastha of vranashopha
size 5-15cm
All cases of cellulitis without complications
irrespective of gender |
|
| ExclusionCriteria |
| Details |
Patients in septicemia
patients who required debridement
patients with uncontrolled DM
Patients with HIV And other immunocompromised diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of punarnava kwath with punarnava ointment glycerine mgso4 dressing in vranashopha with respect to cellulitis in 7 days |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature of vranashopha according to ayurveda & to cellulitis in 7 days according to modern.
To study the duration in reduction of symptoms of cellulitis within 7 Days |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/11/2024 |
| 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
|
This Study has planned to assess the efficacy of punarnava kwath with punarnava ointment in vranashopha to provide better option for treatment as one of the karmas of punarnava is said to be shothaghana,vedanasthapan,dahashamak,kandughana. Cellulitis is common soft tissue infection that is percived as simple to diagnose and manage. preservation of cellulitis occur if the infection is properly identified and treated. skin is the first defence mechanism in innate immunity.vranashopha(cellulitis) usually occur due to loss of integrety of skin. |