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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Significant improvement in the signs and symptoms of Vataja Ostakopa
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Significant improvement in the signs and symptoms of Vataja Ostakopa
Time Frame: Pre-assessment- 0th day | Post-assessement-15th day | Follow up- 22nd day
Secondary Outcomes
- Generation of in-depth analysed data on the different aspects of the disease.(Generation of data on possible adverse drug reaction.)