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CTRI Number  CTRI/2025/03/081927 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the Effect of Manjistha Face Pack and Manjistha Herbal Wash in Daily Skincare Routine 
Scientific Title of Study   A Randomised Open Labelled Comparative Clinical Study to Evaluate the Varnya Effect of Manjistha Mukha Lepa and Manjistha Kwath Mukh Prakshalan as an Upkrama of Dincharya  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ritu Barthwal 
Designation  MD SCHOLAR 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road

Kurukshetra
HARYANA
136118
India 
Phone  7042963630  
Fax    
Email  rutvi.17.bh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ritu Barthwal 
Designation  MD SCHOLAR 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road


HARYANA
136118
India 
Phone  7042963630  
Fax    
Email  rutvi.17.bh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ritu Barthwal 
Designation  MD SCHOLAR 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road


HARYANA
136118
India 
Phone  7042963630  
Fax    
Email  rutvi.17.bh@gmail.com  
 
Source of Monetary or Material Support  
Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana 136118 India  
 
Primary Sponsor  
Name  Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana 
Address  Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana 136118 India 
Type of Sponsor  Other [Government Ayurvedic College] 
 
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 
Dr Shital S Mahadik  Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118
Kurukshetra
HARYANA 
9468475757

shitalsingla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KARSHNYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-prakShAlana-karma, प्रक्षालन-कर्म (Procedure Reference: Susruta Chikista 24/14, Procedure details: Face washes once daily with Manjistha kwath for 30 days.)
(1) Medicine Name: Manjistha, Reference: Charak Sutra 4/8, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 30 Days
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Susruta Chikista 24/63, Procedure details: Manjistha lepa is made fresh and applied all over face and rinsed off with normal water twice a week for 30 days.)
(1) Medicine Name: Manjistha, Reference: Charak Sutra 4/8, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(ml), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patients above the age of 18 years and below the age of 30 years.
2.Patient who are fit for lepa.
3.Patient willing to participate in the clinical trial with signed consent form and will be once informed verbally and in writing of all the informations concerning the study procedure and study objectives.
4.Patients of both genders (male/female)
 
 
ExclusionCriteria 
Details  1.Patients below the age of 18 years and above the age of 30 years.
2.Patients having Vyanga, nyacha, Mukhdushika.
3.Patient who are suffering from any fungal or bacterial infections or any skin infestations or who are under medication with antibiotics and antifungal drugs.
4.Patients having history of any Chronic or systemic illness and underwent recent abdominal surgeries.
5.Patient participated in any clinical trial within last 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To clinically assess the efficacy of Manjistha lepa and Manjistha Mukha Prakshalan on complexion (varna)  Follow up for the objective criteria will be done on 0, 7th, 14th, 21st, 28th & 35th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study about Mukha Lepa
2.To study about Mukha Prakshalan
3.To study about varnya effect of Manjistha
 
Follow up for the objective criteria will be done on 0, 7th, 14th, 21st, 28th & 35th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/04/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Each person’s definition of beauty is unique. Nowadays, individuals are becoming  more aware of their physical attractiveness.The body’s most visible organ is the skin.

In addition to its structural and functional significance, the skin plays a major role in an individual’s physical and emotional health. Humans have an innate desire to have beautiful, healthy skin.

A gorgeous face attracts us all. We find them attractive, enjoy staring at them, and wish we could own one. What we as humans consider to be "beautiful" has been studied by numerous researchers and others. These characteristics include symmetry, large, evenly spaced eyes, white teeth, a well-proportioned nose, and, of course, a flawless complexion. The most important factor in determining someone’s beauty is their skin tone.

Any external preparation made by combining ayurvedic herbs with water, honey, milketc. Is referred as a ‘Lepa.’(1)

An old-aged Ayurvedic skincare technique called Mukhlepa entails mixing herbs into a paste, applying it evenly to the face and neck, and then leaving it on for fifteen to twenty minutes. It is then cleaned with lukewarm water.It aids in the skin’s exfoliation, which helps the skin tone restore to its original shade. It improves the general vitality and health of the skin.Mukhlepa ought to be a part of one’s Dincharya. By promoting the formation of collagen, improving skin complexion, and minimizing fine lines and wrinkles, it helps to lessen the appearance of ageing.(2)

Another such Dincharya procedure is Mukh Prakshalan i.e. using a decoction of water to cleanse face and eyes. Warm water balances the vata and kapha doshas and makes the face more radiant by eliminating dryness, while cold water one the other hand, stops bleeding, reduces acne and leaves the skin looking clear and young. Ayurveda suggests using Shital jala, Billavodaka on by UVA and UVB rays. Additionally, it helps with a variety of allergic disorders, including eczema, psoriasis, scabies, acne, and zits. It can even be used to treat broken heels.(4) kshaya or Amalaki kshaya to wash your face and eyes. Diseases like Neelika, vyanga,Mukhashosha, Pittika and raktapitta are alleviated by it. Washing face with milkresults in Mukhadoshahara and snigdhata in mukha.(3)

The textile industry uses Indian madder, i.e.Manjistha as a natural red coloring ingredient. It is utilized during the processing of arecanut to enhance the astringent flavor of the supari betel nut and lengthen its shelf life. The part that is used is the stem and roots. Nowadays, the entire section is employed in practice. It harmonizes sharp and bitter flavours. Its potency is hot. It is a common ayurvedic medication used to treat skin conditions like dermatitis and eczema.Its botanical name is Rubia cordifolia Linn, and it is a member of the Rubiaceac

 family.The plant has high levels of starch, salt, mangistin, grancin, and zenthgin in addition to yellow genoside.The herb is well-known for stimulating the liver and spleen, improving complexion, and purifying the blood.  It also contains flavonoids which inhibits excessive melanin secretion, thus helps in hyperpigmentation and correcting dark spots and even skin tone. It is also utilized as an anti-toxic herb in Chinese medicine.Because of its blood-purifying qualities, which aid in eliminating toxins from the blood, it also aids in the treatment of numerous skin ailments. It lowers the chance of developing wrinkles, blemishes, spots, fine lines, and dark circles, in addition to protecting the skin from oxidative radical damage brought

 
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