| CTRI Number |
CTRI/2024/07/070784 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Vranaropana taila against Jatyadi taila as external application in Dushtavrana with special reference to Neurogenic ulcers. |
|
Scientific Title of Study
|
A comparative add on clinical trial to evaluate the effectiveness of Vranaropana taila against Jatyadi taila as external application in Dushtavrana with special reference to Neurogenic ulcers. |
| 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 Sajiya K T |
| Designation |
P G Scholar |
| Affiliation |
VPSV Ayurveda College, Kottakkal |
| Address |
Department of Shalyatantra
VPSV Ayurveda College, Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9497654714 |
| Fax |
|
| Email |
sajiyashaikhazar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunitha P V |
| Designation |
Professor |
| Affiliation |
V P S V Ayurveda College, Kottakkal |
| Address |
Department of Shalyatantra
V P S V Ayurveda College
Kottakkal
P O Edarikode
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunitha P V |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College, Kottakkal |
| Address |
Department of Shalyatantra
VPSV Ayurveda College
Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aryavaidyasala Kottakkal GMP certified institute, India, Kerala, Malappuram ,P O Kottakkal, Pin code 676503 |
|
|
Primary Sponsor
|
| Name |
V P S V Ayurveda College Kottakkal |
| Address |
V P S V Ayurveda College, Edarikode PO , Kottakkal, Kerala,676501 |
| Type of Sponsor |
Other [[Aided 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 Sajiya K T |
Aryavaidyasala Hospital, Kottakkal |
Room number 2
Malappuram
KERALA |
9497654714
sajiyashaikhazar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) Vaidyaratnam P S Varier Ayurveda College Kottakkal |
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: Susrutha samhitha chikitsastana, Procedure details: : vrana will be cleaned with triphala kwatha,a guaze impregnated with vranaropana taila will be kept over vrana & will be dressed with sterile pad.Dressing will be done once in a day for 8 hours.Then it will be cleaned with lukewarm water & will be dressed with sterile pad. the procedure will be continued for 28 days.)
(1) Medicine Name: Varnaropana taila, Reference: Ayurveda yoga sangraha, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 28 Days(2) Medicine Name: Manjishtadi kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 90(ml), Frequency: bd, Duration: 28 Days(3) Medicine Name: kaishora guggulu, Reference: sahasrayoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: susrutha samhitha, Procedure details: vrana will be cleaned with triphala kwatha,a guaze impregnated with Jatyadi taila will be kept over vrana & will be dressed with sterile pad.Dressing will be done once in a day for 8 hours.Then it will be cleaned with lukewarm water & will be dressed with sterile pad. The procedure will be continued for 28 days.)
(1) Medicine Name: Jathyadi taila, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 28 Days(2) Medicine Name: Manjishtadi kashaya, Reference: sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 90(ml), Frequency: bd, Duration: 28 Days(3) Medicine Name: Kaisora guggulu, Reference: sahasrayoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects satisfying diagnostic criteria of Neurogenic ulcers
2Subjects within the age limit of 21-70 years irrespective of gender
3 Participants with informed consent |
|
| ExclusionCriteria |
| Details |
1 Uncontrolled Diabetes mellitus HbA1c more than 7.5
2 Ulcer size more than 10 cm
3 Known cases of TB, HIV, Malignancy, Lepromatous ulcer, Burns |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Number of ulcers
2 Size of ulcers
3 Granulation tissue formation
4 Epithelialisation
6 Drainage amount |
0th, 7th, 14th, 21st,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
05/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A comparative add on superiority trial is planned in non healing ulcers with special reference to neurological ulcers to compare the topical application of vranaropana taila against jatyadi taila. Conventionally antibiotics are used for treating chronic ulcers, but antibiotic resistance is a biggest challenge now a days. At the same time plant derived antibiotics acts predominantly by breaking the cell wall and cell membrane of microbes which ultimately leads to their death.Even though some formulations are being used for treating chronic ulcers, there are some medicines that are yet to be explored. Here an attempt is made to explore Vranaropana taila as topical application in chronic ulcer. The outcome measurements will be done by using some assessment criteria like granulation tissue, epithelialisation, drainage amount etc. |