| CTRI Number |
CTRI/2016/02/006687 [Registered on: 26/02/2016] Trial Registered Prospectively |
| Last Modified On: |
15/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Collection and Sodhana of Snuhi and its effect on padadari |
|
Scientific Title of Study
|
A study on collection and shodhana of a source drug of Snuhi (Euphorbia caducifolia Haines. ) kshira (latex) & its clinical efficacy on Padadari
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashi Gupta |
| Designation |
MD Second year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Room No 63 P G Boys Hostel IPGT and RA Jamnagar
Room No 63 P G Boys Hostel IPGT and RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824999823 |
| Fax |
|
| Email |
shashi.gpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R N Acharya Guide Shashi GuptaScholar |
| Designation |
MD Second year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Dravyaguna Department,IPGT and RA Jamnagar, Gujarat Ayurved University, Jamnagar
Dravyaguna Department,IPGT and RA Jamnagar, Gujarat Ayurved University, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashi Gupta |
| Designation |
MD Second year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Room No 63 P G Boys Hostel IPGT and RA Jamnagar
Room No 63 P G Boys Hostel IPGT and RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824999823 |
| Fax |
|
| Email |
shashi.gpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamnagar arid zone Gujarat ,India |
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA Jamnagar Gujarat 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 |
| Dr Shashi Gupta |
IPGT & RA |
OPD no.17 Gujarat Ayurved University, Jamnagar
Jamnagar
GUJARAT |
9824999823
9824999823
shashi.gpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicscommitteeIPGTandRAJamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cracks associated with Pain
Cracks associated with bleeding
Ruksha (Roughness in the feet)
Ruksha (Dryness of the feet )
Kandu (Itching of the feet)
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Euphorbia caducifolia Haines. |
As per required for affected area of patches,Local application, morning & night, 21 days duration
|
| Comparator Agent |
NL |
NL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having age between 18-70 years with classical sign and symptoms of of padadari.
2.Patients having chronic exposure to water, dust, dryness who have developed cracks on heels.
|
|
| ExclusionCriteria |
| Details |
1)Patients having age less than 18 years and more than 70 years.
2)Patients with any suppurative infections, chillbains, etc.
3)Patients with history of allergic or hypersensitive reaction to any ingredients of the regimen.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Relief in cracks associated with Pain |
21 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Ruksha(Roughness in the feet)
Ruksha(Dryness of the feet)
Kandu(Itching of the feet)
Daha(Burning sensation) |
upto 21 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
04/04/2016 |
| 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="6"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Clinical observations will be published in peer reviewed journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
An open labelled pilot clinical study was carried out to assess the role of Snuhi kshira gel on patients of padadari after getting approval of IEC (Ref no: PGT/7/-A/ethics/2015-16/1470) dated 25.08.2015. The study was registered in CTRI (CTRI/2016/02/006687). Clinically diagnosed 30 cases of padadari among the patients visiting the OPD of Dravyaguna dept. were supplied with (25gms) Snuhi gel for topical application(as per required surface area of padadari) for a duration of 21 days. 26 patients continue the treatment and four patients drop out due to personal reasons. 3.85 % got complete remission, 19.23% mild improvement, 61.54% moderate improvement, 7.69 marked improvement and 3.85% patients shows no effect of treatment. A considerable change in pain, burning sensation and itching score among the patient. No adverse reactions are observed during the study. |