| CTRI Number |
CTRI/2024/10/074838 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomised controlled clinical study of dustingof dhataki lodhra powder in comparison with dusting of betadine powder in clean wound |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study of Dusting of Dhataki Lodhradi Churna
In Comparison with Dusting of Betadine Powder in Shuddha Vrana |
| 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 Nimish N Dhulap |
| Designation |
PG scholar M.S Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalay, pune |
| Address |
Tilak Ayurved Mahavidyalaya,
1st floor, Shalyatantra Dept.,
580/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8308136057 |
| Fax |
|
| Email |
nimishdhulap28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj B Gaikwad |
| Designation |
Asso. Professor Shalyatantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalaya,
1st floor, Shalyatantra Dept.,
580/2 Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimish Namdev Dhulap |
| Designation |
PG scholar M.S Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalaya,
1st floor, Shalyatantra Dept.,
580/2 Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8308136057 |
| Fax |
|
| Email |
nimishdhulap28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalay,
1st floor Shalyatantra department
583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private 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 Nimish Namdev Dhulap |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
OPD no 7, Surgery ward , Tarachand Hospital Rasta peth pune
Pune
MAHARASHTRA |
8308136057
nimishdhulap28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethica Committee , TAMV Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: SUDDHAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avacUrNanam, अवचूरà¥à¤£à¤¨à¤®à¥ | (Procedure Reference: Chakradatta vransoth 38, Procedure details: In shuddha vrana, dusting of Dhataki Lodhra churna will be done for the period of 15 days according to size of vrana)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine powder | In shuddha vrana, group B will be treated with dusting of betadine powder for 15 days, twice in a day. |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Shuddha Vrana irrespective of sex, age, occupation.Fresh incised wounds, lacerated wounds within 24 hours will be selected.
Surgical wound eg. Post op. circumcision wound.Uninfected wounds in process of healing will be selected Non-infected Diabetic wound with healthy granulation |
|
| ExclusionCriteria |
| Details |
Venous, Tubercular, Ischemic, Tropical, Neurogenic, malignant ulcers.
Infected wounds.
Diabetic Wounds having discharge or slough
Patient suffering from HIV, HbsAG.
Wound having dimension more than 6 cm . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain , symptoms, discharge from wound |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in size, daha |
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/10/2024 |
| 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
|
The study will be intervened by the treatment of dusting of dhataki lodhradi churna and Betadine Powder tto group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |