| CTRI Number |
CTRI/2020/12/030064 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Venous Leg Ulcer through Ayurveda |
|
Scientific Title of Study
|
Efficacy of Jaloukavacharana and Kasisadi Taila in the management of Sirajanya Vrana [Venous Leg Ulcer] – An open labelled randomized comparative clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Rajeevan |
| Designation |
MS First year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Shalya tantra 6th Floor IPGT and RA Jamnagar OPD No 1 Sushruth Bhavan IPGT and RA Jamnagar Gujarat 361008 India
Jamnagar GUJARAT 361008 India |
| Phone |
8289843076 |
| Fax |
|
| Email |
reshmacooldoc1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrT S Dudhamal |
| Designation |
Associate Proffessor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Shalya tantra 6th Floor IPGT and RA Jamnagar OPD No 1 Sushruth Bhavan IPGT and RA Jamnagar Gujarat 361008 India
Jamnagar GUJARAT 361008 India |
| Phone |
9428671939 |
| Fax |
|
| Email |
dudhamal@ayurveduniversity.com |
|
Details of Contact Person Public Query
|
| Name |
DrT S Dudhamal |
| Designation |
Associate Proffessor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Shalya tantra 6th Floor IPGT and RA Jamnagar OPD No 1 Sushruth Bhavan IPGT and RA Jamnagar Gujarat 361008 India
Jamnagar GUJARAT 361008 India |
| Phone |
9428671939 |
| Fax |
|
| Email |
dudhamal@ayurveduniversity.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post-Graduate teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for PostGraduate teaching and Research in Ayurveda |
| Address |
Gujarat Ayurved University Jamnagar Gujarat 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Reshma Rajeevan |
PG Hospital IPGT and RA Jamnagar |
PG Hospital Dept of Shalya tantra IPGT and RA Jamnagar Gujarat 361008 Jamnagar GUJARAT |
8289843076
reshmacooldoc1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I878||Other specified disorders of veins, (2) ICD-10 Condition:I878||Other specified disorders of veins. Ayurveda Condition: Sirajanya vrana, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jaloukavacharana |
Group A - 15 patients will be treated with Jaloukavacharana (Leech therapy) once in a week and Kasisadi taila local application once in a day maximum up to 4 weeks. |
| Comparator Agent |
Kasisadi taila |
Group B - 15 patients will be treated with local application of Kasisadi Taila once in a day maximum up to 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed Cases of Venous Leg Ulcer/Ulcers with chronicity of above 15 days
2 Controlled cases of Type 2 Diabetes Mellitus (RBS ≤180mg/dL)
3 Controlled cases of Hypertension (BP ≤ 160/90)
|
|
| ExclusionCriteria |
| Details |
1 Malignant ulcers, tubercular ulcers, syphilitic ulcers
2 Patients of Malignancy of any organ
3 Uncontrolled cases of Hypertension (BP >160/90)
4 Uncontrolled cases of Type 1 and Type 2 Diabetes Mellitus (RBS >180mg/dL).
•Heart diseases like MI, CAD, IHD.
•Patients having embolism, bleeding disorder, arterial occlusion disease and other infective skin disorders.
•Patients with immune-compromised diseases like HIV, HbsAg, Cancer, HCV.
•Sarvanga sopha (Swelling all over the body)
•Panduroga (Pallor/Anemia), Arsha (Haemorrhoids),Udara(Ascites),Sosha (Cachexia), Garbhini (Pregnant woman)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms of Sirajanya Vrana (Venous Leg ulcer) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of the person |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
31/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The research study entitled "Efficacy of Jaloukavacharana and Kasisadi Taila in the management of Sirajanya vrana (Venous Leg Ulcers) – An open labelled randomised comparative clinical trial" has been completed and is summarized below. After screening 67 cases of non-healing ulcers, 31 cases were falling under the inclusion criteria as well as diagnostic criteria. All 31 cases were consented and enrolled for the study from which, 7 cases were dropped out and 24 cases completed the course of treatment and follow up as mentioned in the synopsis of the study. Effect of the therapy Highly significant effect was observed in Group A therapy in Vedana, Kandu and early granulation. Significant effect was seen in Daha, and Srava. Significant reduction in size of the ulcer was seen in Group A patients. Significant results were observed in CT value while no significant results were observed in other parameters like Hb, Total leukocyte count, Eosinophils, Monocytes, Basophils, ESR, BT and RBS. Significant effect of therapy was observed in relieving Vedana, Daha, Kandu and early granulation in patients of Group B. Non-significant effects were observed in reduction of size of the ulcer after therapy though clinically considerable changes were observed in the patients. Significant results were observed in the neutrophils, lymphocytes and BT values. Insignificant effect was observed in parameters like Hb, Total leukocyte count, Eosinophils, Monocytes, Basophils, ESR, CT and RBS. In the comparative effect of therapy, statistically no significant differences were found in the effects of therapy on both the groups, ie, Group A (Jaloukavacharana and Kasisadi taila) and Group B (Kasisadi taila local application) in the management of Venous Leg Ulcer, though clinically better evident outcomes were seen in individual patients of Group A, i.e., Jaloukavacharana followed by Kasisadi taila local application. Jaloukavacharana followed by Kasisadi taila local application was found to be effective against single isolate bacteria specifically gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa along with mixed isolates Escherichia coli+ Pseudomonas aeruginosa by Day 10 of therapy. Kasisadi taila was found to be ineffective against single isolates Escherichia coli and Enterobacter species till Day 30 of therapy and effective against mixed isolates Escherichia coli+ Pseudomonas aeruginosa by Day 30. Overall result of therapy Maximum patients i.e., 41.67% and 25% got complete relief in Group A and Group B from the clinical condition of Venous Leg Ulcer respectively. 50% and 25 % patients got marked improvement in their condition from Group A and Group B respectively while 8.33% and 50% patients got moderate improvement from Group A and Group B respectively. On the basis of the clinical study, observations and results, discussion was written on the review of literature, observations, effect of therapies, mode of action of therapies and anti-microbial effects of the medicine.
The study concluded that Jaloukavacharana and Kasisadi taila shows similar wound healing effect in the management of Sirajanya vrana (Venous Leg Ulcer).
|