A Comparative Study To Evaluate The Efficacy Of Shuntividangadi Grita Nasya And Vidanga Taila Nasya In The Kaphaja Shirashoola With Special Referance to Maxillary Sinusitis.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- X-ray water’s view
Study Overview
Brief Summary
NEED FOR THE STUDY
Shiras occupying the prime place in human body has to beprotected by all means, as it one among *dasha pranayatanas.*Kaphaja shira shoola is oneamong types of shirarogas explained Acharya Sushrutha,characterized by phlegm in throat and face, heaviness in the head, oedema offace and eyelids.
Most of the clinical features are correlated with signs andsymptoms of maxillary sinusitis, this condition is becoming more significant inpopulation because of few nidanas such as Rajo-Dhoomasevana(atmosphericpollutants), Purovatasevana(exposure to wind currents), ambukrida (swimming)sheeta, madhura, guru snigdha ahara.
Kaphaja shira shoola featuresinclude mild/modest headache and heaviness of head. The headache persiststhroughout the day, and it may increase at night. This condition is commonly associated with nasal discharge,nasal obstruction, and postnasal discharge.Sinusitis affects the mucosa of nose and para nasal sinusaffecting approximately 15% population in India. It is seen that increased airpollution and exposure to cold and flu have caused an increase in thiscondition.Over 85% of people with cold inflamed sinus. Theseinflammations are typically brief & mild. Only between 0.5% and 5% peoplewith cold develop true sinusitis. Maxillary sinusitis are most common sites.Conservative treatment is indicated for Maxillary Sinusitislike Antibiotics, nasal decongestant drops, steam inhalation, analgesics.
In this scenario, where there is no effective cure forSinusitis in modern medicine, Ayurvedic line of management may be beneficial.Acharya Sushrutha has mentioned that the patient suffering fromkaphaja shira shoola gets relived from the symptoms by kaphahara,teekshna nasya. Nasya karma is easy to administer, cost effective, easilyacceptable by patients and can be done at OPD level. Considering the abovefactors this study was taken up.So Shuntividangadi Grita is used forNasya as drugs used in this formulation has Kaphahara property.
HYPOTHESIS:
1. 1. Null hypothesis H0 – shuntividangadi grita Nasya and vidangataila Nasya is not having any effect on kaphaja shirashoola.
2.Alternative hypothesis H1- shuntividangadi griita nasya is having better effect than vidanga taila Nasyain reducing kaphaja shirashoola.
3. 3. Alternate hypothesis H2: vidangataila nasya is having better effect than shunti vidanga grita Nasyain reducing kaphaja shirashoola.
4. Alternate hypothesis H3: shuntividangadigrita nasya is having equal effect in reducing kaphaja shirashoolacompared to vidanga taila nasya.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Kaphaja sirashoola Lakshana are observed and included.
- •2.Patient belonging to the age group of 18-60 years.
- •3.Patient are selected irrespective of sex, occupation religion, socio-economic status etc.
- •4.Those who are eligible for Nasya karma.
- •5.Patient with X-ray showing haziness in Maxillary Sinus are included.
Exclusion Criteria
- •1.Patients associated with other systemic illness.
- •2..Patients with complication of maxillary sinusitis.
- •3.Patients suffering from headache which is caused due to migrane/tension headach.
- •4.Patients with contraindications of Nasyakarma were excluded.
Outcomes
Primary Outcomes
X-ray water’s view
Time Frame: 58 days
Secondary Outcomes
- 1.Headache(2.Heaviness of head)