| CTRI Number |
CTRI/2024/12/078478 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Jeerakadi lepa and manjistha lepa in vyangya with reference to melasma |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study to evaluate the efficacy of Jeerakadi lepa and Manjistha lepa in the Management of Vyangya w.s.r 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 Mahesh Kishan Warwade |
| Designation |
MD Kaychikista Scholar (Ayurveda) |
| Affiliation |
Dr VJD Gramin ayurved mahavidyalaya patur |
| Address |
OPD no 3 Kaychikista Department Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola
Akola MAHARASHTRA 444501 India |
| Phone |
7385555004 |
| Fax |
|
| Email |
warwademahesh5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vikram Singh chavan |
| Designation |
Professor Department of Kaychikista |
| Affiliation |
Dr VJD Gramin ayurved mahavidyalaya patur |
| Address |
OPD no 3 Department of Kaychikista, Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola
Akola MAHARASHTRA 444501 India |
| Phone |
8275730257 |
| Fax |
|
| Email |
tinavikramsing2006@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vikram Singh chavan |
| Designation |
Professor Department of Kaychikista |
| Affiliation |
Dr VJD Gramin ayurved mahavidyalaya patur |
| Address |
OPD no 3 Department of Kaychikista, Dr VJD Gramin ayurved mahavidyalaya patur near Renuka mata Mandir patur tal patur dis akola
Akola MAHARASHTRA 444501 India |
| Phone |
8275730257 |
| Fax |
|
| Email |
tinavikramsing2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikista,Dr VJD Gramin Ayurved Mahavidyalaya, Patur, Dis-Akola, Maharashtra, India Pin-444501 |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Department of Kayachikista Dr.VJD Gramin Ayurved Mahavidyalaya, Patur Dist-Akola Pin-444501
Maharashtra,India |
| Type of Sponsor |
Private medical college |
|
|
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 Mahesh Kishan Warwade |
Dr. VJD Gramin Ayurved Mahavidyalaya, Patur patur |
OPD No.3,Department of Kaychikista,Dr.VJD Gramin Ayurved Mahavidyalaya, Patur, near Renuka Mata Mandir,Patur Tal-Patur,Dis-Akola Akola MAHARASHTRA |
7385555004
warwademahesh5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Akola |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita Madhyam khand, Procedure details: Procedure details: दà¥à¤°à¤µà¥à¤¯à¤®à¤¾à¤°à¥à¤¦à¤¶à¤¿à¤²à¤¾à¤ªà¤¿à¤·à¥à¤Ÿà¤‚शà¥à¤·à¥à¤•ंवासदà¥à¤°à¤µà¤‚तनॠ। देहेपà¥à¤°à¤²à¥‡à¤ªà¤¨à¤¾à¤°à¥à¤¥à¤¤à¤²à¥à¤²à¥‡à¤ªà¤‡à¤¤à¥à¤¯à¥à¤šà¥à¤¯à¤¤à¥‡à¤¬à¥à¤§à¥ˆà¤ƒ ॥ [ शा.सं.म. 5 / 2] All ingredients of Manjistha Lepa will be taken in equal quantity & mixed it with water (as per requirement) & prepared paste.)) (1) Medicine Name: Manjistha lepa, Reference: वà¥à¤¯à¤™à¥à¤—ेषॠचारà¥à¤œà¥à¤¨à¤¤à¥à¤µà¤—à¥à¤µà¤¾ मञà¥à¤œà¤¿à¤·à¥à¤ ा वा समाकà¥à¤·à¤¿à¤•ा । लेपः सनवनीता वा शà¥à¤µà¥‡à¤¤à¤¾à¤¶à¥à¤µà¤–à¥à¤°à¤œà¤¾ मयी ।। १६ ।।... अ.हृ.उ.32/16], Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita Madhyam Khand , Procedure details: Procedure details: दà¥à¤°à¤µà¥à¤¯à¤®à¤¾à¤°à¥à¤¦à¤¶à¤¿à¤²à¤¾à¤ªà¤¿à¤·à¥à¤Ÿà¤‚शà¥à¤·à¥à¤•ंवासदà¥à¤°à¤µà¤‚तनॠ। देहेपà¥à¤°à¤²à¥‡à¤ªà¤¨à¤¾à¤°à¥à¤¥à¤¤à¤²à¥à¤²à¥‡à¤ªà¤‡à¤¤à¥à¤¯à¥à¤šà¥à¤¯à¤¤à¥‡à¤¬à¥à¤§à¥ˆà¤ƒ ॥ [ शा.सं.म. 5 / 2] All ingredients of Jeerakadi Lepa will be taken in equal quantity & mixed it with water (as per requirement) & prepared paste.))) (1) Medicine Name: Jeerakadi lepa , Reference: दà¥à¤µà¥‡ जीरके कृषà¥à¤£à¤¤à¤¿à¤²à¤¾à¤ƒ सरà¥à¤·à¤ªà¤¾à¤ƒ पयसा सहः । पिषà¥à¤Ÿà¤¾à¤ƒ कà¥à¤°à¥à¤µà¤¨à¥à¤¤à¤¿ वकà¥à¤¤à¥‡à¤¨à¥à¤¦à¥à¤®à¤ªà¤¾à¤¸à¥à¤¤à¤µà¥à¤¯à¤™à¥à¤—लाञà¥à¤›à¤¨à¤®à¥ ।।... अ.हृ.उ.32/18], Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical features of Vyanga.
2.Patients willing to sign the informed consent form.
3.Patient of either gender, irrespective of socioeconomic status.
4.Patients not using any topical treatment for melasma prior to enrollement in study. |
|
| ExclusionCriteria |
| Details |
1.Patients taking O.C.Pills.
2.Patients suffering from other skin disorder and other systemic disorder.
3.Patients associated with any serious systemic disorders.
4.History of Allergy to topical application.
5.Cancer of skin.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms of Vyangya like
1. Black spot
2.Brown spot
3.itching
All the above symptoms Will be decreased and control over Vyangya with reference to 2.melasma |
7,14,21,28 Days Symptoms will be Observed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased in symptoms of Vyangya & hyperpigmmantion
Like darkness black spot |
18 month |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
25/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="6" |
|
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
|
Ayurveda is an eternal life science and the main aim of Ayurveda is promotion of health and eradication of the diseases. The Beauty and Attraction of individual is reflected in the skin’s health. Skin diseases though afflicts bodily but gives lot of psychological disturbances.
Vyanga is the one of the Kshudra Roga, which is characterized by Neeruja (painless), Shyava Varna Mandalas (bluish black patches) occurring especially on the face. While considering the pathogenesis of Vyanga, involvement of Pitta is more and it is Rakta Pradoshaja Vyadhi.
On the basis of clinical features it is correlated with melasma, or facial melanosis, one of the hyper pigmented disorders. Melasma is a common acquired hypermelanosis that affects sun- exposed areas of skin. This study is important since melasma is a disease causing mental side effects in patients, due to darkness and opacity of the skin; therefore, the treatment of melasma in terms of its psychological complication is of particular importance.
Hyperpigmentation (melanosis) is a group of disorders characterized by abnormally darker skin that results from increase in the concentration of pigment, which occurs either due to increased number of melanocytes or increase activity of melanocytes.
Now a day’s Vyanga becomes one of the biggest problems of the society. Many people are suffering from Vyanga today. Among them women are commonly found due to changes occurring during pregnancy and use of cosmetic supplements. In the context of Vyanga both Shodana and Shamana Chikitsa are explained in the form of Raktamokshana, Lepa, Abhyanga and oral medication".
Need of the study -
Pigmentation are seen especially on cheeks, nose, forehead and chin. The Prevalence of melasma varies between 1.5% and 33.3% depending on the population. Its Prevalence in women is around 50%- 70% in Pregnancy stage. In men its 20.5-25.38% of the cases.
Acharya charaka has broadly classified chikitsa under three main headings, namely Antah Parimarjana, Bahir Parimarjana and Shastra Prranidhana. Lepa kalpana is the Upakalpana, which comes under Bahir Parimarjana Chikitsa . The Lepa which is applied on the face gives strength to the muscle of eyes, cheeks has to be thick which enhance face complexion which in turns cures Vyanga. Alepa normalizes Rakta and Pitta.
So, the Lepa which is one of the forms of external application for skin diseases is taken for this study. Jeerakadi Lepa & Manjishtha Lepa is mentioned in the Ashtanga Hrudaya Chikitsathana for the management of Vyanga Chikitsa. |