| 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] |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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 |
|
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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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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 |