| CTRI Number |
CTRI/2025/02/081036 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to study the effect of Udumbar Twak Kwath Dhawan in the management of Dushta vrana with special reference to infected wound. |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED OPEN CLINICAL STUDY TO EVALUATE THE EFFICACY OF UDUMBAR TWAK KWATH DHAVAN IN THE MANAGEMENT OF DUSHTA VRANA WITH SPECIAL REFERENCE TO INFECTED 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 Mayuri Sawarbandhe |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Shalya Tantra OPD number 6 Siddhakala Ayurveda Mahavidyalaya Sangamner Siddhakala Ayurveda Hospital Pimparne Road Sangamner Khurd Sangamner 422605 Ahmednagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7400107654 |
| Fax |
|
| Email |
mayusawarbandhe13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Saraf |
| Designation |
Head Of Department Shalya Tantra |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Siddhakala Ayurveda Mahavidyalaya Sangamner Siddhakala Ayurveda Hospital Pimparne Road Sangamner Khurd Sangamner 422605 Ahmednagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naimish Saraf |
| Designation |
Head Of Department Shalya Tantra |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Siddhakala Ayurveda Mahavidyalaya Sangamner Siddhakala Ayurveda Hospital Pimparne Road Sangamner Khurd Sangamner 422605 Ahmednagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya and research centre Pimparne Road Khurd Sangamner Ahmadnagar MAHARASHTRA 422605 |
|
|
Primary Sponsor
|
| Name |
Dr. Mayuri Sawarbandhe |
| Address |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| 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 Mayuri Sawarbandhe |
Siddhakala Ayurveda Mahavidyalaya |
Shalya Tantra OPD number 6 Siddhakala Ayurveda Mahavidyalaya Pimparne Road Sangamner Khurd Sangamner
Ahmadnagar
MAHARASHTRA |
7400107654
mayusawarbandhe13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Siddhakala Ayurveda Mahavidyalaya |
Approved |
| Ethics Committee Siddhakala Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Udumbar Twak Kwath, Reference: Sushrut sutrasthan 38/49, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - Udumbar Twak Kwath with Tablet of Cefixime 200mg BD | | 2 | Comparator Arm (Non Ayurveda) | | - | EUSOL | EUSOL wash with Tablet Cefixime 200mg BD |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptoms of Dushta Vrana (Infected wound)
2. Dushta vrana within Size length of 5cm to 10cm, Depth up to 2cm. |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from major illness like cirrhosis, Ascites, Renal failure DM, TB, Leprosy, pregnancy, Jaundice, Varicosity, HIV 2.Patient with malignancy.
3.Bleeding disorder (increased BT and CT)
4. Diabetic wounds
5.Multiple wounds
6. Anemic patient Hb<7 g/dL |
|
|
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 Udumbar Twak Kwath Dhavan in the management of Dushta Vrana with special reference to infected wound |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Study the properties of Udumbar Twak Kwath like Shodhan
2) To compare the shodhan properties of udumbar twak kwath & EUSOL |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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
|
Infected wound mostly requires surgical debridement to stabilize the patient as well as to promote healing processes. But surgical debridement means longer hospitalization, wound care and economical expenses which affect person physically as well as mentally. Udumbar Twak having properties of Shodhana and Ropana, might be less painful and may require minimum expenditure in comparison with other drugs. Hence it can be most affordable, convenient and non-surgical treatment (Para surgical) modalities in developing countries which can provide relevant treatment modalities in health medical sciences. Also Udumbar Twak possesses antibacterial anti-inflammatory and wound healing properties.
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