| CTRI Number |
CTRI/2024/11/076795 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Dushta Vrana with Ashwagandhadi Lepa |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Ashwagandhadi Lepa in the management of Dushta Vrana with special reference to Non Healing Ulcer |
| 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 Saurabh Singh |
| Designation |
MS PG Scholar |
| Affiliation |
Government pg ayurved college and hospital varanasi |
| Address |
Opd 25 department of shalya tantra government pg ayurved college and hospital varanasi uttar pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9720371737 |
| Fax |
|
| Email |
singhsaurabh0796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrigank Shekhar |
| Designation |
Lecturer department of shalya tantra |
| Affiliation |
Government pg ayurved college and hospital varanasi |
| Address |
Opd 25 department of shalya tantra government pg ayurved college and hospital varanasi uttar pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453788863 |
| Fax |
|
| Email |
drmrigank.bhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tina Singhal |
| Designation |
Lecturer department of rachna sharir |
| Affiliation |
Government pg ayurved college and hospital varanasi |
| Address |
Department of rachna sharir government pg ayurved college and hospital varanasi uttar pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9450374357 |
| Fax |
|
| Email |
drtinasinghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd 25 department of shalya tantra government pg ayurved college and hospital varanasi 221002 |
|
|
Primary Sponsor
|
| Name |
Government pg ayurved college and hospital chaukaghat varanasi uttar pradesh |
| Address |
Government pg ayurved college and hospital chaukaghat varanasi uttar pradesh 221002 |
| Type of Sponsor |
Government medical college |
|
|
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 Saurabh Singh |
Government pg ayurved college and hospital chaukaghat varanasi uttar pradesh |
Opd 25 department of shalya tantra government pg ayurved college and hospital chaukaghat varanasi uttar pradesh
Varanasi
UTTAR PRADESH |
9720371737
singhsaurabh0796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government P.G. Ayurvedic College and Hospital, Chaukaghat, Varanasi U.P, Mahayogi Guru Gorakhnath Ayush University Gorakhpur, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: sushruta sutra sthan 18/3, Procedure details: 1.The wound is cleaned with normal saline water. 2.Wound is dried with sterilised gauge piece. 3.Lepa is applied on the affected area. 4.Dressing is secured with bandages without compromising the circulation of afffected area. )
(1) Medicine Name: Ashwagandhadi Lepa, Reference: Ashtang Hridayam uttar sthan 25/52, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Duration: 60 Days
)
(1) Medicine Name: Ashwagandhadi Lepa, Reference: Ashtang Hridayam Uttar sthan 25/52 Bhav prakash Madhyam khanda 47/64, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients irrespective of age,sex and occupation will be consider for the study.
2.Non Healing ulcers will be included in the study.
3.Wound without history of systemic manifestation.
4.Controlled Diabetic Patients.
5.Patients having Clinical features of Nija/Agantuja Dushta Vrana i.e foul smell,pus discharge,pain,burning sensation and edema. |
|
| ExclusionCriteria |
| Details |
1.Dagdha vrana/Burns
2.Known cases of Malignant wounds,Anaemia,Syphilis and Leprosy.
3.Septicemia
4.Gangrenous Wounds,Neurogenic Ulcer,Ischemic Ulcers,Arterial Ulcers
5.Patients having Viral Markers Reactive.
6.Known Cases of Tuberclosis etc.
7.Ulcers present on pressure areas of body.
8.Bedsores ulcers.
9.Those who are physchologically not fit for the treatment.
|
|
|
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 |
1.Pus discharge
2.Slough formation |
60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.pain
2.Burning sensation
3.Oedema |
30 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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="1" |
|
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
|
Interventional
study
Patient
suffering from dushta vrana will be selected from opd and ipd of government pg
ayurved college and hospital varanasi
Total
patient-60
Treatment
plan-1.the wound will be cleaned with normal saline.
2.then
wound will be dried with sterlised gauge piece
3.ashwagandhadi
lepa is applied on affected area followed by sterile pads as absorbent layer.
4.then
dressing will be done with bandages without compromising with the blood
circulation of affected area.
Duration-60
days
Follow up-
15 days for 2 months
|