| CTRI Number |
CTRI/2017/06/008931 [Registered on: 28/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the effect of the Drug Akkini chooranam (Internal) and Veera mezhugu (external) in patients having pain in sole of the foot |
|
Scientific Title of Study
|
An open clinical trial of Siddha drugs “Akkini chooranam†(internal) and “Veera mezhugu†(external) in the treatment of “Kuthikaal vaatham†(Plantar fasciitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Padmavathi |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 3
Department of Sirappu Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9092146820 |
| Fax |
04422381314 |
| Email |
dr.padma90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NJ Muthukumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 3
Dept Of Sirappu Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
04422381314 |
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Padmavathi |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 3, Dept Of Sirappu Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9092146820 |
| Fax |
04422381314 |
| Email |
dr.padma90@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai 600047 |
| 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 M Padmavathi |
Ayothidoss Pandithar Hospital |
Room No 3, Dept Of Sirappu Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai 600047
Chennai
TAMIL NADU |
9092146820
04422381314
dr.padma90@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 |
Kuthikaal vaatham (Plantar fasciitis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Akkini chooranam (Internal) and Veera mezhugu (External) |
1.5 gm of Akkini chooranam will be administered orally twice a day
for a period of 48 days.Veera mezhugu (Q.S) will be issued to apply externally |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain and tenderness in the sole of the foot while on walking and standing |
|
| ExclusionCriteria |
| Details |
1.H/o Cardiac diseases
2.H/o Diabetes mellitus
3.H/o Rheumatoid arthritis
4.H/o Chronic kidney disease
5.Pregnancy and lactation
6.Septic arthritis
7.Gonococcal arthritis
8.Psoriatic arthritis
9.Patient with any other serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of the study is pain relieving and it will be assessed by Universal Pain assessment scale (before and after treatment). Restricted movement assessment scale (before and after treatment) and Questionnaire.
|
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Associated factors of Kuthikaal vaatham by Age, Sex, BMI and occupation. |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/12/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of AKKINI CHOORANAM in patients with KUTHIKAAL VATHAM (PLANTAR FASCIITIS). In this trial 40 patients will be recruited and the trial drug will be administered 1.5 gm twice a day for a period of 48 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research |