CTRI/2025/03/082981 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On:
15/08/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Ayurvedic treatment of hyperpiggmentation over face( Melasma) with Mukhakantikara Lepa and Manjishthadi Vati
Scientific Title of Study
Evaluation of classical as well as present era causative factor of Vyanga w.s.r. to Melasma and its management by Manjishthadi Vati and Mukhakantikara Lepa
Trial Acronym
nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
shital uddhavrao sarang
Designation
M.D. scholar
Affiliation
Institute of teaching and research in ayurveda , jamnagar ,gujarat
Address
Department of Rognidana 5th floor academic building ITRA Jamnagar,Gujarat. Gurudwara road, opp. B Division police station, near reliance smart, valkeshwari,park colony, jamnagar, gujrat Jamnagar GUJARAT 361008 India
Phone
7972248405
Fax
Email
shitalsarang2212@gmail.com
Details of Contact Person Scientific Query
Name
Dr Darshna Pandya
Designation
Professor, HOD
Affiliation
Institute of teaching and research in ayurveda , jamnagar ,gujarat
Address
Department of Roganidana 5 th floor,academic building,ITRA Jamnagar,Gujrat Gurudwara road, opp. B Division police station, near reliance smart, valkeshwari,park colony, jamnagar, gujrat Jamnagar GUJARAT 361008 India
Phone
9099011095
Fax
Email
darshnapandya73@gmail.com
Details of Contact Person Public Query
Name
shital uddhavrao sarang
Designation
M.D. scholar
Affiliation
Institute of teaching and research in ayurveda , jamnagar ,gujarat
Address
Department of Rognidana 5th floor academic building ITRA Jamnagar,Gujarat Gurudwara road, opp. B Division police station, near reliance smart, valkeshwari,park colony, jamnagar, gujrat Jamnagar GUJARAT 361008 India
Phone
7972248405
Fax
Email
shitalsarang2212@gmail.com
Source of Monetary or Material Support
Institute of teaching and research in ayurveda, Jamnagar,Gujarat
Primary Sponsor
Name
Institure of Teaching and Research in Ayurveda
Address
Opp city B divison,near reliace smart ,gurudwara road Jamnagar,Gujarat,361008
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: VYANGAH,
(Procedure Reference: Susrut samhita,by Kaviraj Ambikadutta Shastri,Edited with Ayurveda Tatva Sandipika Hindi commentary ,Sutrasthan Vranlepanbandhavidhi18/6 Chaukhambha Publications,New delhi p-97 , Procedure details: Patient will be advised to take Mukhakantikara Lepa in required quantity mix with water to form paste then to apply on affected area.The Lepa is to be applied in upward direction & very thin layer is to be made.Lepa is to apply during day time only and to be removed as soon as it gets dried.
) (1) Medicine Name: Mukhakantikara Lepa, Reference: Chakradatta of Chakrapanidatta, with the hindi commentary of vaidyapabha, Ramnath dvivedy editors, chaukhamba Sanskrit sansthan Varanasi reprint edition 2005 ,55/45 p-315 , Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Duration: 2 Months
3
Comparator Arm
Procedure
-
lepa, लेप
(Procedure Reference: Susrut samhita,by Kaviraj Ambikadutta Shastri,Edited with Ayurveda Tatva Sandipika Hindi commentary ,Sutrasthan Vranlepanbandhavidhi18/6 Chaukhambha Publications,New delhi p-97, Procedure details: Patient will be advised to take Mukhakantikara Lepa in required quantity mix with water to form paste then to apply on affected area.The Lepa is to be applied in upward direction & very thin layer is to be made.Lepa is to apply during day time only & to be removed as soon as it gets dried. ) (1) Medicine Name: Mukhakantikara Lepa, Reference: Mukhakantikara Lepa, Reference: Chakradatta of Chakrapanidatta, with the hindi commentary of vaidyapabha, Ramnath dvivedy editors, chaukhamba Sanskrit sansthan Varanasi reprint edition 2005 ,55/45 p-315, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Duration: 2 Months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
patients fulfilling the diagnostic criteria of Vyanga and patient willing to participate in the study
ExclusionCriteria
Details
patient age below 18 years and more than 55 years.Hyperpigmentation other than melasma like Acanthosis nigricans, niveous ota etc.Hyperpigmentation caused due to malignant melanoma, liver disease, congenital mark.Post inflammatory pigmentation or open wound on face.Patient suffering from contagious skin diseases, hereditary skin disorder.Pregnant or lactating women.Patient not willing to participate in the study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Improvement MASI score and improvement MELASQOl
(Melasma Quality of Life scale)
8 weeks
Secondary Outcome
Outcome
TimePoints
Improvement in Woods lamp examination
8 weeks
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "83" Final Enrollment numbers achieved (India)="83"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/05/2025
Date of Study Completion (India)
17/08/2026
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
In this study, a total of 83 patients of Vyanga having age between 18-55 years and willing to participate were enrolled and surveyed to evaluate causative factor. Diagnosis was made on the basis of the presence of classical features of Vyanga, characterized by painless, thin, bluish-blackish discoloration of the facial skin. The depth of pigmentation was assessed by Wood’s lamp examination. Haematological, liver function as well as urine routine microscopic examination were carried out to rule out any underlying pathology.The majority of patients belonged to the 31–40 years age group (41%). Female patients constituted the majority (96%), with most participants being Hindu (95%) and married (90%). Among educational groups, HSC-qualified patients were predominant (36%), followed by graduates (32%). Most participants were housewives (86%). Regarding socio-economic status, the majority (65%) belonged to the middle class, while 77% were from urban areas.Among dietary factors, intake of Lavana Ahara (66%), Ruksha Ahara (65%), Snigdha-Ushna Ahara (63%), and Amla Ahara (60%), Tikshna Ahara (53%), Tikta Rasa (28%), Pishatanna (20%) were observed.Among the dietary habits, Vishamashana (51%) and Anashana/Alpashana (47%) were commonly observed, followed by Vidagdhajirna (33%) and Adhyashana (11%).Lifestyle-related factors like Atapa Sevana (72%), followed by Ratrijagarana (34%) and Ativyayama (28%) were observed.Psychological factors were predominantly Krodha (anger) (88%), followed by Chinta (stress) (86%) and Shoka (emotional grief) (20%) were observed.Risk-ratio analysis revealed a higher chance of the observed Nidanas with Vyanga.Among these, Anger (RR = 7.3) and Stress (RR = 6.5) showed the highest magnitude of association, followed by intake of Lavana Rasa (RR = 2.39), Ruksha Ahara (RR = 1.86), Snigdha-Ushna Ahara (RR = 1.67), Amla Ahara (RR = 1.51), Tikshna Ahara (RR= 1.12), and Vishamashana (RR = 1.02).Interventional study: Out of surveyed patients of Melasma 32 patients were randomly divided into two groups. Group A received Mukhakantikara Lepa and Manjishthadi Vati and Group B received Mukhakantikara Lepa alone. At the end of the study statistifically highly significant improvement was observed in both the group but on MASI score but percentage wise group A showed better improvement than group B. Further on woods lamp examination Group A showed 92.31% improvement in pigmentation Both groups showed a highly significant improvement in MASI score (p < 0.001), with 48.25% relief in Group A and 21.11% relief in Group B. On examination with Wood’s lamp, decreased pigmentation accentuation whereas in Group B it was 61.4% only with no change in type of melasma in either group.was observed in 92.31% of patients in Group A and 61.54% in Group B, with no change in the type of Melasma observed in either group.