| CTRI Number |
CTRI/2024/10/075578 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two classical external application (lepa) in Hyperpigmentation. |
|
Scientific Title of Study
|
Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Arkaksheeradi Lepa in the Management of Vyanga with special reference to Melasma |
| 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 Devisree Babu T S |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta
Room No 7, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Rd, Udayapura P O, BANGALORE.
Bangalore
KARNATAKA
560082
India |
| Phone |
08951383499 |
| Fax |
|
| Email |
drdevisreebabuts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajitha K |
| Designation |
Principal Professor HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta
Room No 7, Sri Sri College of Ayurvedic Science and Research, 21st km, Kanakapura Rd, Udayapura P O, BANGALORE.
Bangalore
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devisree Babu T S |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta,
Room No 7, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Rd, Udayapura P O, BANGALORE.
Bangalore
KARNATAKA
560082
India |
| Phone |
8951383499 |
| Fax |
|
| Email |
drdevisreebabuts@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research 21st km Kanakapura Road Udayapura P O Bangalore 560082 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Devisree Babu T S |
| Address |
Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura Rd, Udayapura P O, BANGALORE 560082, KARNATAKA, INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Devisree Babu T S |
Sri Sri College of Ayurvedic Science and Research |
Department of Swasthavritta
Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km, Kanakapura Rd, Udayapura P O, BANGALORE.
Bangalore
KARNATAKA |
08951383499
drdevisreebabuts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arkaksheeradi lepa, Reference: Sharangadhara Samhita, Lepanavidhi 11/13, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Lepa churna to be mixed with fresh arkaksheera and applied on the affected areas of face. To be washed off once it begins to dry. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna twak churna lepa, Reference: Bhaishajya ratnavali, Kshudraroga Chikitsa, 60/40, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Arjuna twak churna lepa should be mixed with madhu and applied over the affected areas of face. To be washed off once it begins to dry. |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Melasma of either gender within the age group between 21 – 50 years will be selected.
Subjects with Melasma chronicity less than 5 years.
Subjects fulfilling the diagnostic criteria of Melasma with special reference to Vyanga will be randomly selected.
Subjects who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Individuals with Hyper-pigmentary disorders other than Melasma.
Females on oral contraceptive pills, pregnant women, lactating women.
Hyperpigmentation since birth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Significant decrease in melasma pigmentation based on modified MASI Score.
2.Significant decrease in the colour and number of lesions based on the arbitrary grading and fairness meter scale.
|
1st Assessment – 0 day
2nd Assessment – 15th day
3rd Assessment – 30th day
Follow up (without medication) – 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of in depth analysed data on different aspect of disease and its treatment.
2.Generation of data on possible unexpected drug reaction.
|
1st Assessment – 0 day
2nd Assessment – 15th day
3rd Assessment – 30th day
Follow up (without medication) – 45th day
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/11/2024 |
| 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 Yet Recruiting |
| 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
|
Healthy skin is a reflection of
an individual’s overall health. Any skin conditions especially on face not only
reduces self confidence but also causes stress, anxiety and depression which in
turn impairs the individuals quality of life.
Vyanga is one
among Kshudra rogas, characterised by Niruja and Shyava varna
Mandalas on Mukhapradesha. On the basis of clinical features
of Vyanga, it can be compared to Melasma Melasma is an
acquired hyperpigmentation that is characterized by bilateral irregular brown
macules and patches on sun exposed areas of the face.
Melasma affects 40% of the Indian
population, according to previous studies. Darker skin types and females
are more likely to experience it.In Ayurveda classics many treatment
modalities were explained for Vyanga and Lepa is one among
them, which helps to enhance complexion.
Among
those Lepas, Arkaksheeradi lepa is mentioned
for Mukhakarshnya and could be effective in the management
of Vyanga.
Arkaksheeradi lepa contains Arka Ksheera,
Haridra and Daruharidra.
These Dravyas have Kushtangna, Kandughna, Raktashodhaka, Twak prasadakara and Varnyakara properties
& can aid in depigmentation by removing twak vaivarnya. Hence the study aims to evaluate
the effect of Arkaksheeradi lepa in Vyanga.
|