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CTRI Number  CTRI/2018/08/015311 [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   Study to determine the efficacy of Herbomineral Exfoliating bath powder  
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Exfoliating Herbomineral bath powder in improving skin health, freshness and rejuvenation 
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 Swastha vritta, Yoga OPD, Survey No. 189, O.B. Chordahalli, Udayapura Post, Kanakapura Rd, Bangalore South, Bengaluru, Karnataka 560082

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, Errikkarai Road, KP natham village, Puducherry (PBS Post Office)

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, Errikkarai Road, KP natham village, Puducherry (PBS Post Office)

Pondicherry
PONDICHERRY
605102
India 
Phone  09790635964  
Fax    
Email  sushrutayurveda@gmail.com  
 
Source of Monetary or Material Support  
KVM Research Laboratories, RS No.144/5, Erikkarai Road, KP Natham Village, Puducherry -605102 
 
Primary Sponsor  
Name  KVM Research Laboratories 
Address  Midam Asham, RS No.144/5, erikkarai road, KP natham, Puducherry 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSajitha K  Sri Sri College of Ayurvedic Science and Research   Room No.7, Dept of Swastha vritta, Yoga OPD, O.B. Chudahalli, 21st KM Kanakapura Road, Udayapura P.O., Bangalore -560082
Bangalore
KARNATAKA 		 7760987722

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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Subjects who have all skin types including sensitive and acne prone skin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbomineral Exfoliating Bath Powder  Duration of Study: 30 Days Dosage: 10-15 g of powder to be used daily for bathing Frequency: To be used once per day Description of IP: A poly herbal formulation containing a combination of the following herbs and soils, 1. curcuma amada 2. Psoralea corylifolia 3. phyllanthus emblica 4. terminalia belerica 5. terminalia chebula 6. terminalia chebula young 7. ceasalpinia bonduc 8. abies webiana 9. cyperus rotundus 10. hydichium spicatum 11. pistacia integerrima 12. acorus calamus 13. In a base of soils (Fullers earth & Red Soils )  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Any male or female adults between 18-60 years
2.Subject who is willing and is able to comply with all trial requirements.
3.Subjects with all skin types
4.Subjects who have sensitive and acne prone skin.
5.Subjects who have hyper pigmentation problems with skin irritation.
 
 
ExclusionCriteria 
Details  1.Subjects with chronic disorders
2.Population containing children and geriatric individuals
3.Pregnant women and nursing mothers
4.Subjects who have the habit of smoking and drinking alcohol
5.Subjects who are undergoing other cosmetic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of patient response to topical application of IP in terms of skin health, freshness and rejuvenation  Day 0, Day 15 and Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Exfoliating Effect of bath powder  Day 0, Day 15 and Day 30 
 
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   This study is to understand the efficacy of Herbomineral - a combination of different herbs and soils when used as a bath powder during a daily bath routine. This study involves 30 patients and the duration is 30 days. Each patient will be instructed to use the herbomineral bath powder instead of soap and the effect of topical application of Herbomineral will be studied and assessed.15 g of Herbomineral bath powder  is to be made into a paste with water. This quantity of Herbomineral is determined to be sufficient for a full body bath and the paste is to be applied externally and washed off with water after 15 minutes.  
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.
 
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