| CTRI Number |
CTRI/2024/09/073703 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchkarma procedure ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Yavadi Lepa in Vyanga with special reference to Melasma |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF YAVADI LEPA IN 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 Vaishnavi Vijaykumar Jalihale |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Opd no.13 department of Panchakarma SMBT ayurved college and Hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9422339245 |
| Fax |
|
| Email |
jalihalevaishnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kurawar |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Opd no.13 department of Panchakarma SMBT ayurved college and Hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8793655354 |
| Fax |
|
| Email |
rashmikurawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Vijaykumar Jalihale |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Opd no.13 department of Panchakarma SMBT ayurved college and Hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9422339245 |
| Fax |
|
| Email |
jalihalevaishnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma SMBT ayurved college and Hospital Nandi hills Igatpuri Nashik 422403
Maharashtra India GMP certified Pharmacy |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Vijaykumar Jalihale |
| Address |
OPD no 13 Department of Panchakarma SMBT Ayurved College and Hospital Dhamangaon Nashik 422403 Maharashtra 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 Vaishnavi Vijaykumar Jalihale |
SMBT Ayurved College and Hospital Dhamangaon |
OPD no 13 Department of Panchakarma SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
MAHARASHTRA |
9422339245
jalihalevaishnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital Dhamangaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L818||Other specified disorders of pigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Pramod Mandalkar author rudra prakashana Ed 2022 Therapeutic procedures of Panchakarma Mukhalepa,,,, Procedure details: Yavadi Lepa-
Material requirements -
Yava churna (Hordeum vulgare)-2gm
Yashtimadhu churna (Glacyrriza glabra)-2gm
Lodhra churna(Symplocos racemosa)-2gm
Water
Spatula
Chair
Poorvakarma
Conduct a general systemic examination using Ashtavidha & Dashavidha Pariksha methods. Record vital data & obtain written consent before the procedure.
Preparation of Yavadi Lepa
Mix equal quantities of Yava, Yashtimadhu, & Lodhra churna with water to make a paste.
Pradhanakarma
Apply the herbal paste over the face, avoiding the eyes, nostrils, & lips, using a spatula. Removal of Lepa Remove the paste before it dries using a water-moistened cotton or soft cloth
Pashchatkarma
After a specified period, scrape off the paste with a spatula & wipe with a cloth. The patient may then wash their face with warm or cold water. Mukhalepa should be applied daily for 14 days.))
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Pramod Mandalkar author rudra prakashana Ed 2022 Therapeutic procedures of Panchakarma Mukhalepa,,, Procedure details: Arjuna twaka Lepa-
Material requirements -
Arjuna twaka churna (Terminalia arjuna)-6gm
Madhu (Apis melifera)
Spatula
Chair
Poorvakarma
Conduct a general systemic examination using Ashtavidha & Dashavidha Pariksha methods. Record vital data & obtain written consent before the procedure.
Preparation of Arjuna Twaka Lepa
Combine Arjuna Twaka churna with Madhu to form a paste.
Pradhanakarma
Apply the herbal paste over the face, avoiding the eyes, nostrils, & lips, using a spatula. Removal of Lepa Remove the paste before it dries using a water-moistened cotton or soft cloth
Pashchatkarma
After a specified period, scrape off the paste with a spatula & wipe with a cloth. The patient may then wash their face with warm or cold water. Mukhalepa should be applied daily for 14 days.))
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age -20 to 50 years of age
Classical signs and symptoms of Vyanga like
Mukhamagatya Mandalam circular patches on face.
Shyavata(dark coloured) Kandu Daha.
Symetric ,reticulated hyperpigmented patches with irregular borders present on centrofacial ,malar , mandibular region .
Patients who will give consent for the use of drug
|
|
| ExclusionCriteria |
| Details |
Vyanga caused due to any systemic disease eg- Dibeties,Cardiovascular disease ,Cushing syndrome
Patients having another chronic skin disease
Vyanga by birth (congenital)
Patients with long term medication like blood thiner
Pregnant women
Immuno compramised disease.
SLE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Yavadi lepa on the signs and symptoms of vyanga |
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Where trial group is more effective than control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/09/2024 |
| 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="3"
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
|
The population based study from India shows prevalence of Melasma is 10.8%.In pathology of Vyanga Vata ,Pitta Doshas are vitiated.It is characterized as Aruja (painles), Tanu(thin layered) ,Shyava(dark patches) ,Mandal( circular patches) that appear on the face.Melasma which is similar to Vyanga is an acquired Pigmentory disorder. In which hypermelanosis of the skin caused due to human melanogenesis.Lepa is commnest treatment for Vyanga. Vyanga is disease which causes depigmentation and affects normal routine of life.so there is a need to find an alternative solution of this problem .present study of randomized controlled trial will be carried out to study the efficacy of Yavadi lepa in Vyanga with special reference to Melasma. For present study subjects between age group 20-50 will be taken irrespective of the religion ,gender ,socioeconomic status. Sample size found 26 but for the sake of convenience it is taken as32,adding prevalence of 20%.Total 64 patients will be taken for the study with 32 patients in Group A(trial group) and 32 patients in Group B(control group). Yavadi lepa is taken in group A(trial group) and Arjuna twaka lepa is taken in GroupB (control group).trial and control drugs will be purchased from GMC certified pharmacy. Procedure will be done with external application for 14 days . All SOP will be followed. All the findings will be entered in case record form .observations will be drawn before, during and after treatment .Result will be drawn with the help of statistical method .Discussion will be done on the basis of observations. Summary will be drawn .conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |