| CTRI Number |
CTRI/2025/08/093285 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of Kanaka tail nasya with and without local application on face in the pateints of Vyanga |
|
Scientific Title of Study
|
An open label randomized controlled trial to evaluate the efficacy of Kanaka tail nasya with and without local application on face in the management of Vyanga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parth Kumar |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room No 29 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
7015873562 |
| Fax |
|
| Email |
parthkm22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashish Mehta |
| Designation |
Professor and Chairperson, PG Department of Panchkarma |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room No 67 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parth Kumar |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room No 29 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
7015873562 |
| Fax |
|
| Email |
parthkm22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri Road Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Other [Government Ayurvedic College and Hospital] |
|
|
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 |
| Parth Kumar |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra |
Room No 29 1st floor Institute for Ayurved Studies and Research Shri Krishna Government Ayurvedic Hospital Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA |
7015873562
parthkm22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् and local application of tail over face | (Procedure Reference: Astanga hrudyam, nasya vidhi adhyaya, 20/9-10, Procedure details: After massaging, oil is instilled in each nostril. Spit the oil that comes in mouth. After that medicated smoking & gargling is done. This will take about 25 minutes. 7 sittings will be done in between 7 to 21 days.)
Secondly, for local application over face, cleanse the face with water. Take 2ml kanaka tail and rub in between the fingertips and apply it over face in circular and upward motion for 5-10 minutes over forehead, cheeks, nose, under eye gently.Leave it for few hours for deep nourishment.)
(1) Medicine Name: Kanaka tail, Reference: Chakradatta , Shudra roga adhyaya, shloka 56-57, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga hrudyam, nasya vidhi adhyaya, 20/9-10, Procedure details: After massaging, oil is instilled in each nostril. Spit the oil that comes in mouth. After that medicated smoking & gargling is done. This will take about 25 minutes. 14 sittings will be done in between 0 to 21 days.))
(1) Medicine Name: Kanaka Tail, Reference: Chakradatta , Shudra roga adhyaya, shloka 56-57, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of vyanga irrespective of gender,religion and economical status.Age group:25 years to 45 years. Patients fit for nasya karma and abhyanga.Patients willing to sign the consent form. |
|
| ExclusionCriteria |
| Details |
Vyanga caused due to any known systemic disease like Addison’s disease, cushing’s syndrome.
Patients with known case of secondary systemic involvement like cardiac diseases etc.Vyanga along with kushta roga to be excluded.Hyper pigmentation caused by known case of tumour like malignant melanoma.Pregnant, mensurating and lactating women.Patient not fit for nasya karma and abhyanga. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the grade of MASI (Melasma area severity index) score of Melasma. |
1st - 0 Day
2nd - After completion of total 14 sittings
3rd - on follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Colour, Size and Number of Mandalas.
Change in lakshanas like Kandu, Rukshta of skin. |
1st - 0 Day
2nd - After completion of total 14 sittings
3rd - on follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="1"
Months="6"
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
|
It is an open label randomized controlled trial to evaluate the efficacy of Kanaka Tail Nasya with and without local application on face in the Management of Vyanga .Vyanga, can be characterized by melasma, manifests as distinct light to dark brown patches of varying shapes and sizes, primarily on sun-exposed areas like cheeks, nose, forehead, and chin. There are two groups, having 20 patients in each group. In group A, only kanaka tail nasya will be given to patient for total 14 sittings (7 sittings than 7 days gap and further 7 sittings ). Similarly in group B , nasya will be given along with local application of kanaka tail over face. After treatement , changes will be observed as per subjective criteria and objective criteria( size, no., colour of patches, MASI score) . On the basis of outcomes and by using statistical tools, result will be concluded. |