| CTRI Number |
CTRI/2025/04/084350 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study To Know The Effect of
Raladi Taila Lipbalm In Dry Lips |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Raladi Taila Application In The Management Of Vataja Ostakopa With Special Reference To Cheilitis Simplex |
| 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 Akshatha B L |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no.6 ,Department of Shalakya Tantra,Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
9741126579 |
| Fax |
|
| Email |
drakshatha1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen B S |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no.6 Department of Shalakya Tantra Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
9019508460 |
| Fax |
|
| Email |
navs009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen B S |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no.6 Department of Shalakya tantra Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka
KARNATAKA
560082
India |
| Phone |
9019508460 |
| Fax |
|
| Email |
navs009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Akshatha B L |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka |
| 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 Akshatha B L |
Sri Sri college of Ayurvedic Science and Research |
Room no 6 Department of Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital ,Kanakapura Road,Udaypura P.O ,Bangalore-560082,Bangalotre,Karnataka
Bangalore
KARNATAKA |
9741126579
drakshatha1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical 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: OSHTHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Raladi Taila, Reference: Yogaratnakara, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtyadi lip balm, Reference: Yogaratnakara, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 21 to 40 years irrespective of gender, occupation, religion, and socio-economic status.
Subjects presenting with classical features of Vataja Ostakopa and Cheilitis simplex under the diagnostic criteria.
Subjects having dry skin of lip below 40% of digital moisture meter.
Subjects willing to undergo trial and sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of any systemic illness.
Subjects suffering with infections that involve lips like herpes labialis, gonorrhoea, syphilis, angular, contact, exfoliative, actinic, glandular, granulomatous, plasma cell cheilitis; viral or fungal etiologies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the signs and symptoms of Vataja Ostakopa
|
Pre-assessment- 0th day
Post-assessement-15th day
Follow up- 22nd day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in-depth analysed data on the different aspects of the disease.
Generation of data on possible adverse drug reaction.
|
Pre-assessment- 0th day
Post-assessement-15th day
Follow up- 22nd day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2025 |
| 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 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
|
Mukha is considered as one of the important part of Urdwajatru, because it reflects the body health by acting as gateway of an alimentary canal. Acharya Sushruta has explained sixty five Mukharogas, among these, there are eight types of Ostakopa - Vataja, Pittaja, Kaphaja, Sannipataja, Raktaja, Medaja, Kshataja and Abhigathaja Ostakopa. Vataja Ostakopa is considered as most common Ostakopa. It is characterized by Karkasha, Parusha, Stabdha, Krishna Varna, Teevraruk, Dalana and Paripatana of lips. The signs and symptoms of Vataja Ostakopa can be considered similar to those of Cheilitis Simplex. It is the most common disorder, characterized by cracking, fissuring and peeling of the skin of the lips. The Prevalence rate of Cheilitis Simplex in India is more than 10 million cases per year and commonly observed in people having dry skin, suffering from dehydration and malnutrition. Cheilitis Simplex is managed through the local application of occlusives such as lip balm, petroleum jelly, emollients, topical corticosteroids and ointments. In Ayurveda classics, the treatment modalities mentioned for Vataja Ostakopa are Sthanika - Snehana Karma, Nadisweda, Upanaha, Pratisarana, Nasya and Murdhni Taila. So, local application of medicated Sneha will be beneficial in Vataja Ostakopa. Acharya Yogaratnakara has mentioned Raladi Taila in the management of Vataja Ostakopa which consist of Rala, Madhuchista, Guda and Tila Taila that has properties like Parushyahara, Rujahara, Puyasravahara and provides Snehana and Ropana effect in Vataja Ostakopa. Hence, in this study an effort has been made to evaluate the efficacy of Raladi Taila in the management of Vataja Ostakopa with special reference to Cheilitis Simplex.
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