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CTRI Number  CTRI/2019/02/017729 [Registered on: 20/02/2019] Trial Registered Prospectively
Last Modified On: 23/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Healing effect of thumari taila and apamarga Kshara taila in Diabetic ulcers management 
Scientific Title of Study   A Comparative clinical assessment of healing effect of Apamarga Kshara Taila and Thumari Taila in the management of Diabetic Ulcer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Foram Joshi 
Designation  Phd Scholar 
Affiliation  INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  B-25, karelibaug society, b/h bright school,VIP road, Karelibaug
Department of Shalyatantra IPGT and RA GAU Jamnagar 361008
Jamnagar
GUJARAT
390018
India 
Phone  9924468211  
Fax    
Email  dr.foramj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR TS DUDHAMAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  DEPARTMENT OF SHALYATANTRA IPGT AND RA GAU JAMNAGAR GUJARAT INDIA
Department of Shalyatantra IPGT and RA GAU Jamnagar 361008
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Foram Joshi 
Designation  Phd Scholar 
Affiliation  INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA 
Address  B-25, karelibaug society, b/h bright school,VIP road, Karelibaug
Department of Shalyatantra IPGT and RA GAU Jamnagar 361008

GUJARAT
390018
India 
Phone  9924468211  
Fax    
Email  dr.foramj@gmail.com  
 
Source of Monetary or Material Support  
IPGT and RA GAU JAMNAGAR 
 
Primary Sponsor  
Name  Institute for Post graduate teaching and research in Ayurveda 
Address  Gujarat Ayurved University Hospital Road Jamnagar 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 
FORAM JOSHI  PG AYURVED HOSPITAL IPGT AND RA  OPD NO 1 DEPARTMENT OF SHALYATANTRA PG AYURVED HOSPITAL IPGT AND RA GAU JAMNAGAR
Jamnagar
GUJARAT 
9924468211

dr.foramj@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: L979||Non-pressure chronic ulcer of unspecified part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  APAMARGA KSHARA TAILA DRESSING local application and bandaging  50 PATIENTS WILL BE TREATED WITH APAMARGA KSHARA TAILA DRESSING local application and bandaging 
Comparator Agent  THUMARI TAILA  50 PATIENTS WILL BE TREATED WITH THUMARI TAILA DRESSING local application and bandaging 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Diagnosed Cases of diabetic ulcer/ulcers
• Patients of age group of 30 - 70 years of either sex.
 
 
ExclusionCriteria 
Details  1. Malignant ulcers, tubercular ulcers, leprotic ulcers, syphilitic ulcers
2. Past history of Tuberculosis
3. Patients of Malignancy of any organ
4. Uncontrolled Hypertension.
• Heart diseases like MI, CAD, IHD
• Patients with HIV, HBsAg, HCV
 
 
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 
Healing of diabetic ulcers  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
PREVENTION FROM AMPUTATION  2 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   28/02/2019 
Date of Study Completion (India) 19/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Two articles with concern to the research work have been published. 
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 “A comparative clinical assessment of healing effect of Apamarga Kshara Taila and Thumari Taila in the management of Diabetic ulcer.” was aimed to evaluate and compare diabetic wound healing effect of Apamarga Kshara Taila and Thumari Taila. Another Objective was to evaluate in vitro antimicrobial effect of both the oils. This trial was summarized in review of literature, including Ayurvedic literature and modern literature of Wound and Diabetic Ulcer.

Drug review comprises classical narration of both medicaments of both the groups. They are: Thumari Taila (Scurinega leucopyrus Willd. & Meull), Apamarga Kshara Taila (Achyrenthus aspera Linn.), Pippali (Piper longum Linn.), Haritaki (Terminalia chebula Retz.), Triphala Kwatha (Decoction of three herbs like, Terminalia bellirica Roxb., Terminalia chebula Retz. and (Embellica officinalis Linn.) and Sanjivani Vati (A herbo mineral preparation). Also, it comprises formulation of both the oils i.e., Thumari Taila and Apamarga Kshara Taila, their pharmaceutical and analytical analysis and microbiological stability study.

In- vitro antimicrobial study consists report of Antibacterial activity of both the oils against S. aureus, E. coli, Pseudomonas aeruginosa and Klebsiella pneumonie in compare to ampicillin. Thumari Taila was reported having anti-bacterial effect against S. aureus. Antifungal assay of both the oils was carried out against Candida albicans, Candida glabrata, Aspergillus and Candida tropicalis in compare to fluconazole. Thumari Taila with dry drug sample was found having anti-fungal activity against Candida albicans, Candida glabrata and Candida tropicalis.

Clinical Study stats the open label comparative clinical study of 80 clinical cases of diabetic ulcer. On the basis of computer-generated random number table, Group A (n=41) cases were treated by applying study drug Apmarga Kshara Taila and Group B (n=39) cases were treated by applying Thumari Taila in diabetic ulcer for 30 days. In both groups, adjuvant drugs like Triphala Kwatha (for local wound cleaning just prior to wound dressing), Pippali Choorna (Piper longum Linn.) (3gm empty stomach with water), Haritaki Choorna (powder of Terminalia chebula Retz.) (6 gm at bed time with Luke warm water) and Sanjivani Vati (125mg each) (four times a day) were given commonly in same dose and duration. All the cases were screened for essential serology, hematology, urology, bio-chemical and radiological investigations prior their enrollment for the study.  The effect of the treatment was assessed on the basis of relief in subjective parameters (odor, peri-wound skin, discharge and pain) and objective parameters i.e., wound size and clinical microbiology. All the cases were followed up for 1 month. The observed results in the study were subjected to statistical calculation to derive final conclusion.  

Discussion of the study was made on all demographic observations, clinical findings and invitro antimicrobial study.  Conclusion of clinical study suggested that both the groups medicaments have shown highly significant effect in healing of diabetic ulcers. Apamarga Kshara Taila has been proven as good as Thumari Taila in relieving subjective criteria like Gandha (odor), Varna (peri-wound skin), Srava (discharge), Vedana (pain) and Akriti (wound size). Both the medicines were also found effective in reducing microbial load of the ulcers and improving unit healing time. From this clinical study, it was concluded that, Apamarga Kshara Taila and Thumari Taila have equal wound healing effect in the management of diabetic ulcers. Hence alternate hypothesis (H1) is rejected and null hypothesis (H0) is accepted i.e., there is no difference between healing effects of Apamarga Kshara Taila and Thumari Taila in the management of Diabetic ulcers.

 
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