CTRI Number |
CTRI/2023/07/055247 [Registered on: 14/07/2023] Trial Registered Prospectively |
Last Modified On: |
30/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A clinical trial to study the effects of two drugs,
jatyadi taila & arjuna taila in patients with varicose ulcer |
Scientific Title of Study
|
An open label controlled clinical trial to evaluate the effectiveness of arjuna taila in dushta vrana(varicose ulcer) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kavya A |
Designation |
PG Scholar |
Affiliation |
S D M Institute of Ayurveda and Hospital |
Address |
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore KARNATAKA 560074 India |
Phone |
9108662989 |
Fax |
|
Email |
kavyaa@sdmayurbangalore.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr KAVYA A |
Designation |
PG Scholar |
Affiliation |
S D M Institute of Ayurveda and Hospital |
Address |
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore KARNATAKA 560074 India |
Phone |
9108662989 |
Fax |
|
Email |
kavyaa@sdmayurbangalore.in |
|
Details of Contact Person Public Query
|
Name |
Dr Parvathy S |
Designation |
Associate Professor |
Affiliation |
S D M Institute of Ayurveda and Hospital |
Address |
Anchepalya, Kumbalagodu post, Bengaluru
Bangalore KARNATAKA 560074 India |
Phone |
9746120528 |
Fax |
|
Email |
drparvathy20@gmail.com |
|
Source of Monetary or Material Support
|
Self
S D M Institute of Ayurveda & Hospital, Anchepalya, Kumbalagodu post, Bengaluru |
|
Primary Sponsor
|
Name |
Dr Kavya A |
Address |
S D M Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru |
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 Kavya A |
S D M Institute of Ayurveda & Hospital |
Department of Shalya tantra, OPD - 21 Bangalore KARNATAKA |
9108662989
kavyaa@sdmayurbangalore.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe Sri Dharmasthala Manjunatheswara institute of ayurveda and hospital bengaluru |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: DUSHTAVRANAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna taila, Reference: Sushruta sutra sthana 38th chapter 48-49 verse, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi taila, Reference: Bhaishajya ratnavali 47th chapter 84 verse, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients diagnosed with varicose ulcer having the features of varicose vein& ulcer presenting with itching, pain, discharge and discolouration of surrounding tissue.
2.Subjects aged between 20-60 years irrespective of gender, religion, socio-economic status & place.
3.Ulcer size within 10cm x 10cm.
4.Chronicity of ulcer upto1year.
5.Subjects irrespective of chronicity of varicose veins.
|
|
ExclusionCriteria |
Details |
1.Patients aged above 60 years.
2.Patients with Deep vein thrombosis, malignancy, arterial diseases, bleeding disorders, cellulitis, gangrene & uncontrolled diabetes mellitus (HbA1c>6.5)
|
|
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 |
•Bates Jensen wound assessment tool
•VAS scale
•Itching
|
Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of life |
Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/07/2023 |
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
|
Dushtavrana
is
a chronic type of wound resulted from varied aetiology. In contemporary
science, it can be clinically correlated to chronic ulcers. Varicose ulcers are
one among chronic venous ulcers. Venous ulceration is the most severe &
debilitating outcome of chronic venous insufficiency in the lower limbswhich affects the quality of life of an individual by pain, itching, altered
appearance, loss of sleep, functional limitations. Venous disease is
responsible for around 85% of all chronic lower limb ulcers in resource-rich
countries. Community based prevalence is 0.1-0.3% in adults(2-4% in elderly).The general line of treatment includes conservative approach such as Bisgaard
method, compression therapy, vaccum assisted dressing, hyperbaric oxygen therapy,
antibiotics, NSAIDs and surgical interventions like Thiersch grafting and laser
ablation have their own shortcomings. Nearly all venous ulcers can be healed,
but even in those who have successful ablation or wear their stockings
religiously, there is a 20–30% incidence of re-ulceration by 5 years.
Sushruta
has explained Shashti upakrama in which specific avastha of vrana
chikitsa are highlighted. It includes shodhanartha
& ropanartha upakrama like kashaya, varthi, kalka, sarpi, taila,
rasakriya and avachurnana. Among them taila possess
kaphavatagna, vranashodhana,
lekhana properties & are
indicated in sadhyovrana, dushtavrana &
dagdhavrana chikitsa.
Lipid soluble drugs can penetrate more rapidly than water soluble drugs at the
cell surface to enter into the circulation very quickly.
Arjuna
is mentioned as one among the drugs of Nyagrodadi
gana which is having kashaya
rasa, ruksha guna, sheetha virya and vranya properties which
could be beneficial in dushtavrana.
It has antioxidant, anti-inflammatory, analgesic, antimicrobial and antiviral
properties. Pre-clinical study conducted on topical application
of Terminalia arjuna showed
significant effect in histopathology and in wound healing.
Considering the above facts, an
attempt is made to conduct clinical study aiming at establishing the
effectiveness of Arjuna taila in Dushtavrana (Varicose ulcer) chikitsa. |