| CTRI Number |
CTRI/2025/04/085108 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate Effects Of Local Application Of Likuchadi Tail Malhar In Management Of Dusta Vran With Special Refferance Varicose Vein Ulcer Of Lower Extremities |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To study Effect Of Local Application Of Likuchadi Tail Malhar In Management Of Dusta Vran With Special Refferance Varicose Vein Ulcer Of Lower Extremities
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidhdesh Subhash Darekar |
| Designation |
PG Scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved Hospital affiliated with Matoshri Asrabai Darade Ayurved College |
| Address |
Matoshri Asarabai Darade Ayurved Hospital, OPD NO 04/05 Ground Floor, Matoshri Asrabai Darade Ayurved College,SND Campus at Babhulgaon Tal -Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9226337090 |
| Fax |
|
| Email |
darekarsidhdesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Nivruttirao Chavan |
| Designation |
Profesor Department Of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved Hospital affiliated with Matoshri Asrabai Darade Ayurved College |
| Address |
Matoshri Asarabai Darade Ayurved Hospital, OPD NO 04/05 Ground Floor, Matoshri Asrabai Darade Ayurved College,SND Campus at Babhulgaon Tal -Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9420694499 |
| Fax |
|
| Email |
Shahu7099@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Nivruttirao Chavan |
| Designation |
Profesor Department Of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved Hospital affiliated with Matoshri Asrabai Darade Ayurved College |
| Address |
Matoshri Asarabai Darade Ayurved Hospital, OPD NO 04/05 Ground Floor, Matoshri Asrabai Darade Ayurved College,SND Campus at Babhulgaon Tal -Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9420694499 |
| Fax |
|
| Email |
Shahu7099@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved College And Matoshri Asarabai Darade Ayurved Hospital Babhulgaon Tal Yeola Dist - Nashik Maharastra 423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarabai Darade Ayurved college |
| Address |
Department Of Shalyatantra Matoshri Asrabai Darade Ayurved College and Shalyatanta OPD,Matoshri Asarabai Darade Hospital Babhulgaon |
| 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 Sidhdesh Subhash Darekar |
Matoshri Asarabai Darade Ayurved College and Hospital |
Matoshri Asarabai Darade Ayurved Hospital OPD no 04/05 Shalya OPD Ground Floor Matoshri Asarabai Darade College SND Campus Babhulgaon TAL- Yeola Dist- Nashik
Nashik
MAHARASHTRA |
9226337090
darekarsidhdesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Matoshri Asarabai Darad Ayurved College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Tail Malhar, Reference: Research Paper, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 20(mg), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: , Route: , Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 15 Days, Reference: , Route: , Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Likuchadi Tail Malhar , Reference: Bharat bhavishya Ratnakar khand 4, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 20(mg), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: NA, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Ulcer In Lower Leg
2. Oedema Or Hyperpigmentation in Lower Leg
3.Eczematous Or Burning Sensation and Pus Discharge From Ulcer
4.Redness and Itching in and Around Ulcer
Patient Presented With 2 OR More Above Clinical features are Included For Study |
|
| ExclusionCriteria |
| Details |
1.Patients Having DVT(Deep Vein Thrombosis), Embolism,Bleeding Disorder, Artrial Occlusion Disease And Other Skin Disorder
2.Patient Suffering From Any Systemic Disease e.g. Hpertension, COPD , DM
3.Age below 18 and Above 70
4.Nurological Condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters Will Be noted Down
Before and After treatment
1.Pain
2.Gandha
3. Varna
4. Granulation Tissue
5. strva
6. vran akruti
7. Size of wound |
0th ,7 th and 15 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Evaluate Shodhan Ropan Properties Of Likuchadi Tail Malhar
2.To Study Management Of Dusta Vran W.S.R. Varicose Vein Ulcers
3. To Compare Wound Healing Properties Of likuchadi Tail Malhar With Jatyadi Tail Malhar |
15 Days |
1. To Evaluate Shodhan Ropan Properties Of Likuchadi Tail Malhar
2.To Study Management Of Dusta Vran W.S.R. Varicose Vein Ulcers
3. To Compare Wound Healing Properties Of likuchadi Tail Malhar With Jatyadi Tail Malhar |
15 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)
|
28/04/2025 |
| 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 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
|
Acharya Sushruta, the famous Indian Surgeon gave basics of Vrana, its etiopathogenesis and management occupies prominent place in Sushruta Samhita. Acharya Sushruta is one among the few to recognize the different stages of wound healing. There are sixty treatment modalities mentioned for Vrana which is the largest and it itself reveals the importance of Vrana in which Vrana Shodhan, Ropana is mentioned. In Ayurveda, varicose Vein ulcer can be correlated with Dusta vrana. In Ayurveda, the comprehensive management of all vranas is exclusively described by Acharya Sushruta under shashthi upakarma (sixty procedures) He mentioned the term Dushtavrana which has clinical features which resembles to the non– healing type of wound according to present medical science. There are lot of drugs in different formulations, described for vrana ropan (wound healing) according to its site, types, chronicity but, the management of vrana, particularly dustavrana (non-healing ulcer) is still a challenge for surgeons. Varicos vein Ulcer, also known as Stasis ulcer. It occurs due to chronic venous insufficiency caused by improper functioning of venous valves of the lower limb. The conservative treatment of varicose vein ulcers includes standard wound dressing, wearing of support stockings and rest with legs elevated whenever possible along with diet and lifestyle modifications. The high recurrence along with severity of symptoms makes it a prominent object of concern and interest in terms of finding newer, more effective, more convenient, economical modalities of Management Likuchadi Tail Malhar have Potential Shodhan and Ropan Elements which helps In better healing of the Varicose vein ulcers |