| CTRI Number |
CTRI/2018/08/015310 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
11/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effect of external application of Snigdhkanti Ayurvedic Skin Healing Cream |
|
Scientific Title of Study
|
A Prospective, Randomized, Self-Controlled 21 day Clinical Study to evaluate the effect of topical application of Snigdhkanti Ayurvedic Skin Healing Cream. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sajitha k |
| Designation |
PI - Professor, Dept of Swastha vritta |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no 7, Dept. of Swasthavritta, Yoga OPD, O.B. Chordahalli, Udayapura Post, Kanakapura Rd, Bangalore
South, Bengaluru, Karnataka 560082
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
07760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushrut Badhe |
| Designation |
CEO |
| Affiliation |
KVM Research Laboratories |
| Address |
KVM Research Laboratories,
RS No.144/5, Erikkarai Road, KP Natham Village,Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
09790635964 |
| Fax |
|
| Email |
sushrutayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushrut Badhe |
| Designation |
CEO |
| Affiliation |
KVM Research Laboratories |
| Address |
KVM Research Laboratories, RS No.144/5, Erikkarai Road, KP Natham Village,Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
09790635964 |
| Fax |
|
| Email |
sushrutayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVM Research Laboratories,
RS No.144/5, Errikkarai Road,Kp Natham Village, Puducherry-605102 |
|
|
Primary Sponsor
|
| Name |
KVM Research Laboratories |
| Address |
Midam Ashram, RS NO.144/5, Erikkarai Road, KP natham, Puducherry |
| Type of Sponsor |
Research institution |
|
|
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 Sajitha K |
Sri Sri College of Ayurvedic Science and Research |
Room no 7, Dept. of Swasthavritta, Yoga OPD, O.B. Chudahalli, 21st
KM Kanakapura Road,
Udayapura P.O.,
Bangalore -560082
Bangalore
KARNATAKA |
9790635964
sajithak96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subject who is willing to give consent and is able to comply with all trial requirements including subjects with all skin types, with cracked lips, cracks on skin, undereye darkness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Snigdhkanti Neem Sandal Cream |
Duration: Total 21 Days
Dosage: Liberal topical application of cream on topical area as per direction of Physician.
Frequency:
To be applied once daily or as per direction of Physican
Description of Investigational agent:
A purely natural Ayurvedic Proprietary formulation containing oils azadirachta indica, cocus nucifera, santalam album, olea europaea, phyllanthus emblica and curcuma amada in a base of cera alba |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Any male or female adults between 18-65 years
2.Subject who is willing to give consent and is able to comply with all trial requirements.
3.Subjects with all skin types
4.Subjects who have cracked lips, cracks on skin, excessive dry skin, skin rash, itchiness of skin and other related fungal conditions
5.Subjects who have under-eye darkness
6.Being mentally competent and able to understand all study requirements and sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
1.Subjects with chronic diseases like severe liver, renal, cardiac or brain diseases.
2.Pregnant or lactating women
3.Allergic to any medication
4.With a history of alcohol and/or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of topical application of Snigdhkanti Ayurvedic formulation as a skin healing cream. |
Day 0, Day 10, Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess its efficacy in nourishing and softening the skin. |
Day 0, Day 10, Day 21 |
|
|
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 1 |
|
Date of First Enrollment (India)
|
17/08/2018 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A 21 day self-controlled study on the effect of topical application of Snighdkanti- a 100% natural ayurvedic cream is to be conducted. A total number of 30 subjects are to be recruited as per the inclusion criteria. The
cream is to be liberally applied on the target area as per area of topical
application. The quantity of Snigdhkanti Neem Sandal Cream is to be determined
by the physician
At the end of the trial the data gathered on Day 0, Day 10 and Day 21 will be assessed, analyzed and the results and discussions will be recorded.
This study will be
conducted in compliance with the protocol approved by the IEC. No deviation
from the protocol will be implemented without the prior review and approval of
the IEC except where it may be necessary to eliminate an immediate hazard to a
research subject. In such case, the deviation will be reported to the IEC as
soon as possible. |