Comparative clinical trial to evaluate the efficacy of Baladi Ghritamanda Nasya and Ksheerabala Taila Nasya in the Management of Vataj Shirashoola
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Sane guruji Arogya Kendra
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- A clinical study to evaluate efficacy of Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache.
Study Overview
Brief Summary
This study is open labelled randomised comparative clinical trial to evaluate the effect of Baladi Ghritamanada Nasya 2 drops in each nostril once a day for 7 days in comparison with Ksheerabala Taila Nasya given same as Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache. The primary outcome will be effect of Baladi Ghritamanda Nasya and Secondary outcome will be comparison between trial drug and control drug in the management of Vataj Shirashoola w.r.t. Headache.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients suffering from symptoms of Vataj Shiashoola i.e. Shankha Ativedana, Bhru Ativedana, Lalat Ativedana 2)patients of age group 20 to 60 yrs 3)patients of eiter gender will be included in the study 4)patients yogya for Nasyakarma.
Exclusion Criteria
- •patients suffering from Sinusitis,systemic disorder like Hypertension, Diabetes, 2)Secondary Headache caused by Meningitis, Tumour, Encephalitis 3)Pregnancy and Lactation.
Outcomes
Primary Outcomes
A clinical study to evaluate efficacy of Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache.
Time Frame: The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.
Subjective Parameters(by using grades and Visual analogue Scale)-Shankha Ativedana,Bhru Ativedana,Lalat Ativedana
Time Frame: The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.
Other subjective parameters-Severity of headache, Frequency of headache,Duration of headache
Time Frame: The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.
Secondary Outcomes
- Comparision between efficacy of Baladi Ghritamanda Nasya and Ksheerabala Taila Nasya in Vataj Shirashoola w.r.t. Headahe.(Total duration of study will be 18 months)