| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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. |