| CTRI Number |
CTRI/2025/09/094296 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study will be performed to understand the effect of prepared ayurvedic medicine ( Gairikadi pratisarana which is an ointment) in participants of vataja oshthaprakopa which is cracked lips which includes symptoms like dryness, roughness, cracked lips and blakish pigmentation of lips. |
|
Scientific Title of Study
|
An exploratory clinical trial to study the efficacy of Garikadi pratisaran in vatajaoshthaprakopa. |
| 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 NILIMA AMRUTE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE |
| Address |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARAN PUNE MAHARASHTRA - 411044
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARAN PUNE MAHARASHTRA - 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
7498320485 |
| Fax |
|
| Email |
nilimasamrute@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NILIMA AMRUTE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE |
| Address |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARAN PUNE MAHARASHTRA - 411044
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARAN PUNE MAHARASHTRA - 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
7498320485 |
| Fax |
|
| Email |
nilimasamrute@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AISHWARYA SUDHAKARRAO JADHAV |
| Designation |
PG SCHOLAR |
| Affiliation |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE |
| Address |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARAN PUNE MAHARASHTRA - 411044
SHIVTIRTH NIWAS SANKET NAGAR BHAVSAR CHOWK NANDED 431605
Pune
MAHARASHTRA
411044
India |
| Phone |
08446373022 |
| Fax |
|
| Email |
aishwaryasjadhav410@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE |
| Address |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25 NIGDI PRADHIKARANPUNE MAHARASHTRA - 411044 |
| 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 AISHWARYA SUDHAKARRAO JADHAV |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE AND AYURVED RUGNALAYA |
PDEAS COLLEGE OF AYURVEDA AND RESEARCH CENTRE 3RD FLOOR SHALAKYATANTRA DEPARTMENT SECTOR 25, NIGDI PRADHIKARAN, PUNE, MAHARASHTRA - 411044
Pune
MAHARASHTRA |
08446373022
-
aishwaryasjadhav410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: OSHTH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GAIRIKADI PRATISARAN, Reference: GADANIGRAH BHAG 3 CHAPTER 5 SHLOK 65, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: FOR LOCAL APPLICATION ON LIPS |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing minimum 3 signs and symptoms of VatajaOshthaprakopa described as per Ayurvedic Texts as follows.
1.Karkasha (Rough)
2.Parushta (Dryness)
3.Sthabdhata (Immobile)
4.Krushnavarni (Blackish)
5.Tivraruja (Severe pain)
6.Dalan (Cracked lip)
7.Paripatan (peeling or shedding of skin). |
|
| ExclusionCriteria |
| Details |
Mucocele of lip
Severe dry lip
Tumour of lip
Carcinoma of lip
Traumatic lip cracks
Recently undergone oral surgeries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Gairikadi pratisaran inVataja Oshthaprakopa twice a day for 7 days |
To study the efficacy of Gairikadi pratisaran inVataja Oshthaprakopa twice a day for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the adverse effect ifany as,
Itching
Burning sensation
Rashes
Skin pigmentation
Swelling
Redness |
7 DAYS TREATMENT WITH 2 FOLLOW UPS ON 4THAND 8TH DAY |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="1" |
|
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
|
Increased consciousness about one’s beauty and busy life schedule demands for the need of a safe, effective and short term, easily available and at the same time easily applicable remedy to maintain the lips. Thus, gairikadi pratisaran is selected for the present study to evaluate its role in management of vataj oshtharoga As Gairikadi pratisaran contains Ghrut, Taila, Sarjarasa, Siktha, Guda, Saindhav,gairik. All having properties and pharmacodynamics as, Snighda guna - helps inmoisturising Snehana guna - helps in reducing cracks and dryness Vranaropaka guna- helps in cracks healing Sandhananiya guna - helps in treats damaged layer of skinVranaprasadan – reduces pigmentation of lips So, signs and symptoms of VatajaOshthaprakopa will get reduced. No previous work has done on gairikadi pratisaran. As all ingredients are easilyavailable So, it is planned to evaluate the efficacy of gairikadi pratisaran in vatajaoshthaprakopa. |