| CTRI Number |
CTRI/2024/12/078515 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to assess the effect of Leech therapy in patients of venous ulcer |
|
Scientific Title of Study
|
A Single arm
clinical study to evaluate the wound healing efficacy of Jalaukavacarana in the managemnet of venous ulcer (Dusta 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 Vishal Malviya |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001
Kheda
GUJARAT
Kheda GUJARAT 387001 India |
| Phone |
9755605068 |
| Fax |
|
| Email |
malviyavishalraj0407@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD Department of Panchkarma |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001
Kheda
GUJARAT
Kheda GUJARAT 387001 India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
Professor and HOD Department of Panchkarma |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001
Kheda
GUJARAT
GUJARAT 387001 India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sunder Ayurveda teaching pharmacy of J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital, Nadiad GUJARAT 387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001
Kheda
GUJARAT |
| 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 Vishalraj Malviya |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
Department of Panchakarma J S Ayurveda Mahavidyalaya, college road, Nadiad-387001
Kheda
GUJARAT Kheda GUJARAT |
9755605068
malviyavishalraj0407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAM University Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I868||Varicose veins of other specifiedsites. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Susruta Samhita. Dr Ambikadutt Shastri, Chikitsasthana 1st Chapter dvivranachikitsit adhyaya sloka 27-29., Procedure details: The treatment will be done in total 6 sittings of JalaukÄvacÄraṇa along with oral medicine and dressing of the ulcer. JalaukÄvacÄraṇa will be done on every 7th day.
Dressing of the venous ulcer will be done every day with JaÌ„tyaÌ„di oil in between each two sittings of JalaukÄvacÄraṇa. ) (1) Medicine Name: Manjishthadi Kvath, Reference: Sharangadhara samhita By Dr.Brahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Kvathadi Kalpana 2/136-142, p. 102, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 10 Weeks(2) Medicine Name: Kaishora Guggulu, Reference: Shrangadhara samhita By Dr. Brahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Vataka Kalpana; 7/70- 81, p. 136, Route: Oral, Dosage Form: Guggulu, Dose: 900(mg), Frequency: tds, Duration: 10 Weeks |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of age between 18 to 60 years and of both the genders.
2. Active venous ulcers.
3. History of recurrence of venous ulcers.
4. Duration of ulcer up to 3 years.
5. Patient having Hb percentage greater than 10 gm/dl
6. Patients with controlled hypertension and diabetes.
7. Patients who fulfill any three symptoms of the above mentioned diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Uncontrolled Hypertension and diabetes.
3. Duration of ulcer more than 3 years.
4. Known case of diseases like STDs, TB, heart diseases and other disorders which lead to fatal condition for the patients.
5. Patients having embolism, bleeding disorder, and other infective skin disorders.
6. Patients with immune-compromised diseases like HIV, HbsAg, and HCV etc.
7. Patient having Hemoglobin percentage lower than 10 gm/dl
8. Other types of wounds such as Malignant wound, tuberculous wound, leprosy ulcer, and syphilitic ulcers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the efficacy of Jalaukavacharana in the patient of venous ulcer by below given points:
1. VedanÄ (pain)
2. Gandha (Odour of discharge)
3. Varṇa – (Skin Colour Surrounding Wound)
4. Kaṇá¸u (Itching)
5. Venous Clinical Severity Score (VCSS)
6. Wound Measurement
7. Others
|
8 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in Venous clinical severity score (VCSS) |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
08/01/2025 |
| 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 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
|
Ulcer
defined as any break in the continuity of the epithelial tissue. Venous Ulcer
is also known as Stasis ulcer. It occurs due to chronic venous insufficiency
caused by improper functioning of venous valves of the lower limb. Chronic and
prolonged cases of varicose veins yield valve incompetence and stasis of blood
resulting in venous hypertension allowing blood protein fibrinogen leakage
causing fibrin to build up around vessels and prominence of vein preventing
oxygen and nutrients from reaching the cell resulting in ulceration. The
overall incidence rate is 0.76% in men and 1.42% in women. Over the age of 65, the
prevalence increases to 4%. Among leg ulcers, 75% of ulcers are due to
disorders of the venous system. The conservative
treatment of venous ulcers includes standard wound dressing, wearing of support
stockings and rest with legs elevated whenever possible along with diet and
lifestyle modifications, debridement, sterile wound dressing, and at last
life-saving aspects i.e., amputation. Wound care has become increasingly
important given the rise of non-healing wounds and the morbidity associated
with them. But the recurrence rate is quite high, the high recurrence along
with severity of symptoms makes it a prominent subject of concern and interest
in terms of finding more effective, more convenient, economical modalities of
management. SuÅ›ruta SamhitÄ
has exclusively mentioned the treatment regime for ‘Vraṇa’ as JalaukÄvacÄraṇa.
This
study is planned to evaluate the effectiveness of JalaukÄvacÄraṇa in
wound healing in the patients of venous ulcer.
Each of the 20 patients will be treated with JalaukÄvacÄraṇa on every 7th day and daily
dressing with Jatyadi Taila will be done for 6 weeks
along with oral medicaments i.e. Mañjiá¹£thÄdÄ« KvÄtha 40ml twice a day on
empty stomach and Kaiśora Guggulu 3 tablet (each of 300mg) with
warm water for 10 weeks. Patients may have to come to the hospital for follow
up and investigations at every 15th day up to 4 weeks in O.P.D. to record the changes in sign
and symptoms of disease. The changes in the ulcer during the treatment will be observed and assessed by subjective and objective criteria. Subjective criteria includes pain, itching, odour and colour of the ulcer. Objective crieteria includes venous clinical severity score (VCSS) will be assessed before, 2nd, 4th, 6th and 8th week of the treatment.
|