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
|
|
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
|
|
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
|
|
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.â€
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. |