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CTRI Number  CTRI/2022/06/043510 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 22/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Safety and Tolerability of Purim Tablet in Healthy People 
Scientific Title of Study   An Open-Label, Single-Arm Clinical Study to evaluate the Safety and Tolerability of Purim Tablet in Healthy Adults” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dinesh S 
Designation  Consultant pulmonologist 
Affiliation  Xplora Clinical Research Services Pvt.Ltd 
Address  No. 252, Room no.1, Division Clinical Research, 13th Cross, Wilson Garden, Bangalore – 560027

Bangalore
KARNATAKA
560027
India 
Phone  9886125229  
Fax    
Email  bhaktha.dinesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srikrishna 
Designation  Research Scientist 
Affiliation  Himalaya Wellness Company 
Address  302, 3rd floor, clinical pharmacology, R and D, Makali, Bangalore Rural

Bangalore
KARNATAKA
562162
India 
Phone  9731207312  
Fax    
Email  dr.srikrishna@himalayawellness.com  
 
Details of Contact Person
Public Query
 
Name  Kavitha R 
Designation  Senior Research Associate 
Affiliation  Himalaya Wellness Company 
Address  302, 3rd floor, clinical pharmacology, R and D, Makali, Bangalore Rural

Bangalore
KARNATAKA
562162
India 
Phone  9845618212  
Fax    
Email  kavitha.rangaiah@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  302, 3rd floor, clinical pharmacology, R and D, Makali, Bangalore Rural 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
DrDinesh  Xplora Clinical Research services   No. 252, Room no.1, Division Clinical Research, 13th Cross, Wilson Garden, Bangalore – 560027
Bangalore
KARNATAKA 
9886125229

bhaktha.dinesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE indepedent Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy adult volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Purim tablet, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Healthy adult subjects of either sex aged between ≥18 to ≤50 years.
2. Subjects willing to sign informed consent and follow the study procedure.
3. Has not participated in a similar investigation in the past four weeks.
4. Subjects willing to refrain taking any other nutritional supplement during the study period 
 
ExclusionCriteria 
Details  1. Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder.
2. Subjects with any abnormal lab values detected at screening shall be excluded.
3. A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational products (IP).
4. Pre-existing systemic disease necessitating long-term medications.
5. Genetic and endocrinal disorders.
6. Subjects who refused to sign informed consent.
7. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Occurrence of any adverse or serious adverse
events during the study period. 
7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Overall compliance to the study medication  7 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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   N/A 
Date of First Enrollment (India)   30/06/2022 
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="0"
Days="7" 
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)?  

Response - NO
Brief Summary  
Dermatitis is a general term that describes a skin irritation. Dermatitis is a common condition that has many causes and occurs in many forms. It usually involves itchy, dry skin or a rash on swollen, reddened skin. Or it may cause the skin to blister, ooze, crust or flake off. Dermatitis can be acute or chronic or both. Acute eczema (or dermatitis) refers to a rapidly evolving red rash which may be blistered and swollen. Chronic eczema (or dermatitis) refers to a longstanding irritable area. It is often darker than the surrounding skin, thickened (lichenified) and much scratched.
Acne vulgaris is a chronic inflammatory dermatosis which is distinguished by open and/or closed comedones (blackheads and whiteheads) and inflammatory lesions including papules, pustules, or nodules. The bacterium responsible for clinical course of acne is Propionibacterium acnes (P.acnes) which is a gram-positive anaerobe that normally inhabits the skin and is implicated in the inflammatory phase of acne.
Acne lesions occur in the pilosebaceous unit, which consists of the hair follicle, the hair shaft, and the sebaceous gland. The initial step is the formation of microcomedo, both in inflammatory and non-inflammatory acne. It arises from the interplay of 4 pathogenic factors: sebum production, follicular hyper keratinization, microbial colonization of the pilosebaceous unit by Propionibacterium acnes, and the release of inflammatory mediators into the follicle and surrounding dermis.
Purim has antimicrobial, anti-inflammatory, anti-allergic, wound-healing, antioxidant and immunomodulatory properties which synergistically act in managing symptoms of skin conditions. The anti-microbial and immunomodulatory property of Purim helps check infection in acne and prevents infection in susceptible inflammatory skin conditions. The anti-allergic property helps relieve itching associated with dermatitis and relieve symptoms of allergic skin conditions. The anti-inflammatory and property acts on various inflammatory cascades involved in dermatitis and acne and promotes healing. The wound healing and antioxidant property protects tissue from damage and promotes healing.
 
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