| CTRI Number |
CTRI/2025/11/096980 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Treatment Comparison for Healing Infected Chronic Wounds after Cellulitis” |
|
Scientific Title of Study
|
A Clinical Comparative Study Between Shal Twak Kwatha And Panchawalkala Kwatha By Prakshalana In The Management Of Dushta Vrana W.S.R To Post Cellulitic Wound |
| 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 PRATIK MANE |
| Designation |
PG SCHOLAR - SHALYA TANTRA |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no 503/B wing kurla samta sahakari co.op housing society kurla east nehru nagar mumbai 400024
GOKAK ROAD, REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102
MAHARASHTRA
400024
India |
| Phone |
9702430218 |
| Fax |
|
| Email |
pratikman1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RC YAKKUNDI |
| Designation |
GUIDE AND HOD SHALYA TANTRA DEPARTMENT |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
DEPT. OF SHALYA TANTRA,
SHRI SHIVYOGESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL INCHAL GOKAK ROAD, REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102
DEPT. OF SHALYA TANTRA,
SHRI SHIVYOGESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL INCHAL GOKAK ROAD, REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102
Belgaum
KARNATAKA
591102
India |
| Phone |
9986265349 |
| Fax |
|
| Email |
ryakkundi298@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATIK MANE |
| Designation |
PG SCHOLAR - SHALYA TANTRA |
| Affiliation |
SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no 503/B wing kurla samta sahakari co.op housing society kurla east nehru nagar mumbai 400024
DEPT. OF SHALYA TANTRA,
SHRI SHIVYOGESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL INCHAL GOKAK ROAD, REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102
MAHARASHTRA
591102
India |
| Phone |
09702430218 |
| Fax |
|
| Email |
pratikman1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI SHIVAYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SHRI SHIVYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE |
| Address |
GOKAK ROAD REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102 |
| 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 PRATIK MANE |
SHRI SHIVYOGEESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
DEPT. OF SHALYA TANTRA, SECOND FLOOR , SHRI SHIVYOGESHWAR RURAL AYURVEDIC MEDICAL COLLEGE AND HOSPITAL INCHAL GOKAK ROAD, REVANSIDDESWAR NAGAR
INCHAL KARNATAKA 591102
Belgaum
KARNATAKA |
9702430218
pratikman1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL EHTICS CLEARANCE COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHAL TWAK KWATHA , Reference: Description of shal shorea robusta in DhanvantariNighantu 16 and Kaiyadeva Nighantu , Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: SUSHRUTA SAMHITA CHIKITSA 1/74-76, Procedure details: Hands will be cleaned properly before Procedure.
Under Aseptic precautions wound Toileting will be done.
Freshly prepared Shal Twak Kwatha, prepared at low flame will be used at Luke warm temperature for Prakshalana procedure.
Under all aseptic precautions, Prakshalana will be done of Dhusta Vrana by
Shal Twak Kwath to remove the slough and dead tissue.
Daily Prak$halana for 14 days will be done.
After Prakshalana sterile Gauze impregnated with Jatyadi taila will be placed on Dushta Vrana.
Sterile Pad and Sterile Bandage Cloth will be used for Bandaging.
)
(1) Medicine Name: SHAL TWAK KWATHA , Reference: Description of shal shorea robusta in DhanvantariNighantu 16 and Kaiyadeva Nighantu , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 01 Weeks | | 3 | Comparator Arm | Procedure | - | prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: SUSHRUT SAMHITA CHIKITSASTHAN 1/74-76, Procedure details: Hands will be cleaned properly before Procedure.
Under Aseptic precautions Wound Toileting will be done.
Freshly prepared Panchawalkala Kwatha, prepared at low flame will be used at Luke warm temperature for Prakshalana procedure.
Under all aseptic precautions, Prakshalana will be done of Dhusta Vrana by
Panchawalkala Kwatha to remove the slough and dead tissue..
Daily Prakshalana for 14 days will be done.
After Prakshalana sterile Gauze impregnated with Jatyadi taila will be placed on Dushta Vrana.
Sterile Pad and Sterile Bandage Cloth will be used for Bandaging.
)
(1) Medicine Name: PANCHAWALKA KWATHA , Reference: Description of PANCHAWALKALA KWATHA in SUSHRUT SAMHITA18 AND 19 SHARNGDHAR SAMHITA , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 01 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of Age group between 18-70 years.
Subjects will be selected irrespective of Sex, Religion & Occupation Status.
Subjects presenting with the Lakshanas of Dushta Vrana.
Subjects who are fit for kwatha Prakshalan procedure.
Patients with clinical signs and symptoms of Post Cellulitic Wound will be Included.
|
|
| ExclusionCriteria |
| Details |
Subjects who are aged Below 18 years and Above 70 Years.
Subjects with Severe Systemic Disorders like Uncontrolled Diabetes Mellitus, Hypertension that interfere with the course of Treatment.
Subjects with Specific Ulcers due to Malignancy, Gangrene, Tuberculous Wounds.
Patient with Known case of HIV, HBsAg, Tuberculosis, and having immunosuppressive disorder or patient taking immunosuppressive drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THERE IS STATISTICALLY SIGNIFICANT DIFFERENCE IN THE EFFICACY OF SHAL TWAK KWATHA BY PRAKSHALANA IN THE MANAGEMENT OF DUSHTA VRANA ALSO HEALTHY HEALING OF WOUND AND REDUCE PAIN |
GROUP A:
Number of Patients - 20 Patients.
• Procedure - PANCHAWALKALA Kwatha Prakshalana
Intervention Duration - 14 days
Assessment on during treatment - 1st day, 7th day, 14th day.
Assessment on Follow up - 21st day and 28th day.
Total Study Duration - 28Days.
GROUP B:
• Number of Patients - 20 Patients.
• Procedure - Shal Twak Kwatha Prakshalana
Intervention Duration - 14 days
Assessment on during treatment - 1st day, 7th day, 14th day
Assessment on Follow up - 21st day and 28th day
Total Study Duration - 28Days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN PAIN AND BOOTS WITH HEALTHY HEALING OF WOUND AND |
DURATION OF STUDY - 28 DAYS
ROUTE OF ADMINISTRATION - LOCAL APPLICATION
DOSE - QUANTITY SUFFCIENT
FOLLOW UP ON 21ST AND 28TH DAY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
18/11/2025 |
| 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
|
This study is Clinical Comparative Study between Shal Twak Kwatha and Panchawalkala
Kwatha by Prakshalana in the Management of Dushta Vrana W.S.R. to Post
Cellulitic Wound. Vrana can be defined as Breach in the Continuity of body tissue. Ayurveda offers
a comprehensive and time-tested approach to wound management. The term "Vrana"
refers to any breach in bodily tissue integrity, and Dushta Vrana describes wounds that
do not heal within expected time frames, often complicated by infection and vitiated doshas. The ancient texts of Sushruta and Charaka provide detailed insights into the
causative factors and stages of wound development, with a particular emphasis on the
importance of wound cleansing - Shodhana followed by healing promotion - Ropana.
These measures, based on holistic understanding and practical experience, emphasize
removing necrotic material, controlling microbial invasion, and stimulating healthy
tissue restoration.
Within Ayurvedic wound care, Prakshalana or therapeutic wound irrigation
occupies a key role. In the study 40 patients fulfilling Inclusion criteria and complying with
Informed Consent of either sex irrespective of age group between 18 – 70 years were
selected using simple random sampling Technique. Two groups were made GROUP A and GROUP B Each with Number of Patients 20 Patients, Intervention Duration 14 days, Assessment on during treatment 1st day, 7th day, 14th day, Assessment on Follow up on 21st day and 28th day. , Total Study Duration - 28 Days. To provide a comprehensive review of Ayurvedic concepts and interventions
related to Dushta Vrana – Prakshalana, Shal Twak Kwatha, and Panchawalkala
Kwatha and To assess the clinical efficacy of Shal Twak Kwatha Prakshalana in the
management of Dushta Vrana W.S.R. to post-cellulitic wounds. |