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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).



 
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