A randomized controlled clinical study to evaluate the efficacy of Shashilekhadi yoga in the management of Vicharchika with special reference to Eczema
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To study the role of Shashilekhadi yoga in reducing kandu, pidika,
Study Overview
Brief Summary
Skin is the first organ of the body interacting with the environmental agents like biological,
physical, chemical agents. Skin helps in diagnosis of various diseases as it reflects internal and external pathology. In 21st century, continuous changing lifestyle, environment and dietary
habits have made man a main victim of many diseases. Prevalence studies have
demonstrated that between 20-30% of the population have various skin problems requiring attention.
In Ayurveda, all skin diseases are described under the heading of Kushtha. Further it is divided into Mahakushtha and Kshudra kushtha. Vicharchika is one of the kshudra kushtha.
According to the Ayurvedic texts, all types of kushtha have been considered as Tridoshaja and Raktapradoshaja Vikara. Vicharchika is also Tridoshaja and Raktapradoshaja but Acharya explained the Dosha dominancy. Charakacharya explained Kapha dominancy
, Sushrutacharya explained Pitta dominancy. In Madhukosha commentary on Madhavanidana Lakshana of Vicharchika according to dosha is explained.
A similar clinical presentation in modern dermatology is seen in Eczema. It is a medical condition in which patches of skin become rough and inflamed with blisters which cause itching and bleeding. India records more than 10 million cases of Eczema every year, with a
prevalence rate of about 9.1%.
Vicharchika is Kapha dominant Vyadhi. Kaphghna, Ruksha, Kledaghna, Raktashodhaka, treatment is expected. SHASHILEKHADI YOGA containing the Ayurvedic dravyas which are Tikta, Katu rasatmaka, Dipana, Kushtaghna, Kandughna. Shashilekhadi yoga is acting against
the Dosha Dushya Sammurchhana in Vicharchika.
In Khadiradi yoga, Khadir has tikta-kashay rasa and laghu, ruksha guna which act as kapha and pitta shamak, Krimighna, Kledaghna. Nimba has tikta rasa which work on raktavaha strotas. Yakrut and pleeha are moolsthan of raktavaha strotas so it has yakritgamitva effect
which is important for samprapti bhanga of Kushtha (Vicharchika). Kutaki has bhedaniya karma because of its tikta rasa which helps in eliminating the factors responsible for samprapti. Shirish
is having raktashuddhikar (detoxifying) properties. In this way, khadiradi yoga shows kledaghna, kaphaghna, kushthaghna and raktashuddhikar properties.
Taking all above consideration in mind, I have selected my synopsis under the title
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHASHILEKHADI YOGA IN THE MANAGEMENT OF VICHARCHIKA WITH SPECIAL
REFERENCE TO ECZEMA.
Alternative Hypothesis: -
Shashilekhadi yoga is effective in the management of Vicharchika with special reference to Eczema.
Null Hypothesis: -
Shashilekhadi yoga is not effective in the management of Vicharchika with special reference to Eczema.
AIM:-
To evaluate the efficacy of Shashilekhadi Yoga in the management of
Vicharchika with Special Reference to Eczema.
OBJECTIVES:-
- OBJECTIVES-
- To study the role of Shashilekhadi yoga in reducing kandu, pidika,
vaivarnya and srava in Vicharchika.
- To study the role of Shashilekhadi yoga in reducing area of lesion in
Vicharchika.
Type of study - Open randomized controlled clinical prospective study Medium of dissertation English language, which will be supported by Ayurvedic
terminology i.e., in Sanskrit whenever necessary.
Consent -An informed written consent of all patient included in the trial in the language best understood by them will be taken.
Subject Recruitment - Patient will be selected from respective research centre.
Research centre OPD & IPD of respective research centre.
Shashilekhadi Yoga , Khadiradi Yoga
10 gm at morning (empty stomach) 10 gm at morning (empty
stomach) will be given will be given
Follow-up assessment of the patient every week for 4 weeks
Clinical assessment of symptoms like Kandu, Srava, Pidika, Vaivarnya
will be done at the end of study
Final assessment at the end of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
Inclusion Criteria
- •Age -18 to 60 years. 2) Sex.
- •Both Gender 3) Patient with sign and symptoms of Vicharchika like Kandu, Pidika, Vaivarnya and Srava. 4) Understanding and being willing to sign the informed consent form.
Exclusion Criteria
- •Pregnancy and lactating women.
- •Dry Eczema.
- •Immuno-compromised patients like AIDS (HIV positive), HbsAg positive etc.
- •Person With Severe Disorder Like CA, liver disorder, renal or cardiac problems, bed ridden due to chronic illness, patient having uncontrolled DM/HTN.
- •Any complication arising during the treatment of any patient discontinuing the treatment will be excluded.
- •Patient with other debilitating disease like TB/SLE.
- •Patient on medication as, Chemotherapy or Radiotherapy.
- •Clinical H/O Chronic or acute gastritis / Colitis / BS.
- •Mentally retarded patient and psychologically disturbed.
Outcomes
Primary Outcomes
To study the role of Shashilekhadi yoga in reducing kandu, pidika,
Time Frame: Follow up assessment of the patient every week for 4 weeks
vaivarnya and srava in Vicharchika.
Time Frame: Follow up assessment of the patient every week for 4 weeks
2) To study the role of Shashilekhadi yoga in reducing area of lesion in
Time Frame: Follow up assessment of the patient every week for 4 weeks
Vicharchika.
Time Frame: Follow up assessment of the patient every week for 4 weeks
Secondary Outcomes
- 1.To review ayurvedic and modern literature on vicharchika , eczema(2.To asses possible mode of action of Shashilekhadi yoga in vicharchika .)
Investigators
Dr Tejaswini Bhikaji Patil
R.A.Podar Medical College