| CTRI Number |
CTRI/2025/10/095574 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Nasya and Lepa in Vyanga (Melasma) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Varnya Mahakshaya Ksheer-Paka Nasya And Its Lepa In Vyanga (Melasma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravesh Kumar Mukeriya |
| Designation |
Associate Professor |
| Affiliation |
Rishikul Campus Haridwar, Uttarakhand Ayurved University |
| Address |
Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University, Harrawala, Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7417935825 |
| Fax |
|
| Email |
praveshk312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravesh Kumar Mukeriya |
| Designation |
Associate Professor |
| Affiliation |
Rishikul Campus Haridwar, Uttarakhand Ayurved University |
| Address |
Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University, Harrawala, Haridwar Uttarakhand
UTTARANCHAL
249401
India |
| Phone |
7417935825 |
| Fax |
|
| Email |
praveshk312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Patidar |
| Designation |
M.D Scholar |
| Affiliation |
Rishikul Campus Haridwar, Uttarakhand Ayurved University |
| Address |
Rishikul Campus Haridwar, Uttarakhand Ayurved University`, 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9074950423 |
| Fax |
|
| Email |
meghapatidar08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttarakhand Ayurved University Rishikul Campus, Haridwar (Uttarakhand), 249401 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Rishikul Campus, Haridwar (Uttarakhand), 249401
|
| Type of Sponsor |
Government 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 Megha Patidar |
Rishikul Campus Haridwar |
Department of Panchkarma, OPD No. 20
Hardwar
UTTARANCHAL |
9074950423
meghapatidar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L569||Acute skin change due to ultraviolet radiation, unspecified. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridhya, Sutra Sthana , Chapter 20/1, Procedure details: Mridu Abhyanga and swedana followed by Nasya i.e giving medicine through nostrils followed by Kawala with luke warm water.))
(1) Medicine Name: Chandana, Tunga, Padmaka, Usheer, Yashtimadhu, Madhuka, Manjistha, Sariva, Payasya, Sita, Lata, Reference: Charak Samhita, Sutra Sthana, Chapter 4, Shloka 125, Route: Nasal, Dosage Form: Ksheerpaka, Dose: 8(drops), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharandhara Samhita, Uttara Khanda 11/1, Procedure details: Mukha Prakshalana with luke warm water followed by Varnya Mahakashaya Lepa will be applied on the lesion area, in Pratiloma direction and removed before drying up followed by Mukha Prakshalana with luke warm water.)
(1) Medicine Name: Chandana, Tunga, Padmaka, Usheer, Yashtimadhu, Manjistha, Sariva, Payasya, Sita, Lata, Reference: Charak Samhita, Sutra Sthana, Chapter 4, Shloka 125, Route: Topical, Dosage Form: Lepa Churna, Dose: 0.5(NA), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient fulfilling the diagnostic criteria of Vyanga.
2. Patient of age between 20 years to 50 years.
3. Sex- both female and male.
4. Patient fit for Nasya Karma and Lepa |
|
| ExclusionCriteria |
| Details |
1. Skin diseases of face other than Melasma (Vyanga).
2. Hyperpigmentation since birth. Ex- Nervous of ota.
3. Subjects with local inflammatory skin disorders such as herpes infection.
4. Known cases of allergies skin disease of face.
5. Uncontrolled diabetes mellitus and previously diagnosed life threatening and complicated systemic diseases.
6. Known case of Polycystic ovary disorder (PCOD)
7. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
No improvement- 0%-25%
Mild improvement- 25%-50%
Moderate improvement- 50%-75%
Marked improvement- 75%-100% |
15th, 29th, 42th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacrebation in sign and symptoms |
42 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="0"
Months="10"
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
|
Melasma is a skin condition marked by dark brown patches that appear symmetrically on sun-exposed areas of the face, resulting from an excess of melanin. The reasons behind melasma, most significant cited factor is sunlight exposure, followed by childbirth, oral contraceptive pills use, endocrine issues, particularly thyroid abnormalities, cosmetics use, medication use, especially anticonvulsants and photosensitizing agents and genetic impacts. Vyanga Can be compared with Melasma, a prevalent skin condition that causes brown grey spots or bluish grey discoloration on the face, usually on the cheeks, forehead, chin and nasal bridge. In Ayurveda is classified under Kshudra Roga and can be distinguished by the Niruja and Shyava Varna Mandals that are present on the face. Vata and Pitta are the Doshas that are involved in causing Vyanga and they are exaggerated by Krodha, Aayasa and Shoka. If we look at the treatment approach several therapy procedures has specified by the Acharyas like Abhyanga, Lepa,Pradeha, Shamana Nasya, Siraveda, Vamana and Virechana. Therefore, Ksheer-Paka Nasya and Lepa of Varnya Mahakashaya will be used as medication in current study as they are Raktaprasadana, Pitta Shamaka and Vatahara. |