| CTRI Number |
CTRI/2019/05/019246 [Registered on: 21/05/2019] Trial Registered Prospectively |
| Last Modified On: |
16/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of pugai for madhumega viranam |
|
Scientific Title of Study
|
A comparative clinical trail on efficacy of pugai and parangipattai chooranam in the management of madhumega viranam (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 |
Dr R Deepa |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room No 3, Department of Pura Maruthuvam,National Institue Of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8807890942 |
| Fax |
|
| Email |
dr.deeparavi04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrV Mahalakshmi |
| Designation |
Associate professor |
| Affiliation |
National institute of Siddha |
| Address |
OP Room No 3, Department of Pura Maruthuvam,National Institue Of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Deepa |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OP Room No 3, Department of Pura Maruthuvam,National Institue Of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8807890942 |
| Fax |
|
| Email |
dr.deeparavi04@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha
Tambaram Sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
National Institue 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 R Deepa |
National institute of siddha |
OP Room No 3, Department of Pura Maruthuvam,National Institue Of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU |
8807890942
dr.deeparavi04@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: E136||Other specified diabetes mellituswith other specified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient includes diabetic ulcer
2 Inflammation & Induration
3 With or without Pain, Itching, Edema, Fibrinous exudates in the lesions.
4 Patients who are willing to undergo Pugai application.
5 Willing to give blood for investigation whenever required.
5 Willing to attend OPD or admission in IPD for 45 days.
6 Willing to take photograph before and after treatment
|
|
| ExclusionCriteria |
| Details |
1 Extensive and localized Gangrene require amputation
2 Osteomyelitis
3 Deep ulceration with bone, joint involvement
4 Varicose ulcer
• Hansen’s disease
• Tuberculous ulcer
• Any other systemic illness
• Pregnancy and Lactation
• Bronchial asthma
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the therapeutic efficacy of Pugai and Parangipattai chooranam in the management of Madhuega Viranam (Diabetic ulcer). |
18 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the prognosis of Madumega viranmam in variables such as age, sex, occupation etc. |
18 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/05/2019 |
| 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="10"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total
30 selected patients were randomly divided into two groups .15 patients treated with Pugai and Parangipattai chooranam 15 patients treated with Mathan thailam and Parangipattai chooranam. Before
starting the treatment,purgation will be given with Agasthiar kuzhambu-130 mg
at early morning in empty stomach and advised to take rest on next day. From
the next day onwards treatment will be started.The enrolled patients will be advised to visit
the hospital for 45 days |