| CTRI Number |
CTRI/2023/10/058661 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial for Diabetic Foot Ulcer through Siddha medicines |
|
Scientific Title of Study
|
An Open Label Pilot Clinical Trial to Evaluate the Effectiveness of Siddha Herbo Mineral Formulation Vajirakandi Mathirai (Internal) and Mathan Thylam (External) for Madhumega Pun (Diabetic Foot Ulcer) |
| 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 T Monika |
| Designation |
Resident Medical Officer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9488074819 |
| Fax |
|
| Email |
tmoniabi92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Professor and Hospital Superintendent |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G J Christian |
| Designation |
Professor and Hospital Superintendent |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai |
| 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 |
| Dr T Monika |
National Institute of Siddha |
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU |
9488074819
tmoniabi92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Vajirakandi Mathirai and Mathan Thylam |
Vajirakandi Mathirai (Internal) 1 tablet twice a day for 48 days and Mathan Thylam (External) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Known case of type II DM with DFU
1 Age 30 to 65 years
2 Sex Males and Females
3 HbA1c level ranges from 8 to 14 percent
4 Patients taking medications (Integrated medicines or Allopathic) for DM II
5 Patient with Grading I and II of Wagners classification tool will be included in the
study
6 Patient who are willing to participate in the trial will be included |
|
| ExclusionCriteria |
| Details |
1 Patient with any signs and symptoms of Osteomyelitis
2 Ulcer with signs of gangrene
3 Known case of Varicose Ulcer
4 Ulcer in which bone and joints are involved |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To observe the changes as per Wagners classification tool and Photostatic wound
assessment scale for Diabetic Foot ulcer from baseline to end of the treatment
|
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in the lab investigations from baseline to end of the treatment |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
20/10/2023 |
| 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="0"
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
|
Diabetes mellitus is one of the largest global health emergencies of this century. It affects approximately 77 million people in India which is expected to rise to over 134 millionby 2045 . Diabetic complications are retinopathy, macular oedema, cataracts, glaucoma,
neuropathy and ulceration of foot. Diabetic foot ulcer (DFU) is the most typical complication of diabetes mellitus with a poor prognosis due to micro and macrovascular changes (including neuropathy and peripheral vascular disease) as a result of uncontrolled sugar level.
Diabetic foot is a severe public health issue, yet rare studies investigated its global epidemiology. The global diabetic foot ulcer prevalence was 6.3% which was higher in males than in females and higher in type 2 diabetic patients. The prevalence in Asia is 5.5 % .
About 20% to 33% of costs related to diabetes mellitus are used for treatments of diabetic foot . Pathophysiology of Diabetic Foot Ulcer (DFU) depends on both host factors and microbial factors including drug resistance and virulence potentials . Though DFU is
colonized by polymicrobial communities, Staphylococcus aureus is the predominant pathogen. S. aureus, with abundant biofilm formation, virulence factors, multidrug resistance inhibit wound healing and exacerbate wound infection. Several treatment methods, including
Siddha formulations were reported for the management of DFU . However, the management of DFU is still challenging because of multidrugresistant polymicrobial isolates and their virulence, including biofilm. Numerous conventional therapies are available for managing
DFUs. Amputation is the most common clinical result, occurring in 6/1000 patients annually . Amputations have diverse impacts on patients, including impaired physical function, psychosocial trauma, loss of employment and economic stress. To overcome with all the
negative effects of amputation, limb saving treatment modalities are required where integration with other system of medicine is necessary for the benefit of the patient, whereas Siddha system has several internal and external medications for the management and
treatment of DFUS. Saint Yugimuni has described the complication of Madhumegam as Avathaigal, which are ten in numbers. Ulceration of feet/ may be correlated with Avathaigal number eight . As per the evidence of Siddha legend T.V.Sambavasilva pillai Madhumega pun is denoted as Rasa pun. This study deals with the treatment modality of Siddha Herbo mineral formulation formulation Vajirakandi mathirai (Internal) and Mathan thailam (External) in Madhumega Pun (Diabetic foot Ulcer). The Siddha medicine has the potential to heal nearly
90% of diabetic wounds (Diabetic Foot Ulcers) and result in lower blood sugar levels. They may perhaps have a huge impact on the healing process, falling infection rates, amputations, plastic surgeries and humanising the overall quality of life, reducing the monetary burden of treating Diabetic foot Ulcer.
|