To evaluate and compare the effect Brahmivati(oral) and Brahmighrit (nasya) on sleep in nidranasha (Pimary Insomnia) as an adjuvant to sleep hygiene and Shavasana

METHODOLOGY: All the classical texts of ayurveda have been thoroughly reviewed to collect the matter related with approaches for the management of Nidranasha. PubMed etc. databases were searched for SPARK/2024/3341/309 articles published for the same by using key words strategy like Anidra, Nidranasha and primary insomnia and its management etc. The study will be conducted at the OPD/IPD patients & College students if found eligible at ‘X’ college and Hospital by developing a case record form (CRF), based purely on ayurvedic classical references and contemporary science evidences for pre and post subjective assessment of symptoms, quantity and quality of sleep etc.in apparently healthy adults of Primary insomnia. Since, not sufficient Ayurvedic researches are available on these drugs for Primary insomnia particularly, so as an exploratory research total 30 participants in 2 groups (A and B with 15 participants in each group). Randomization list will be prepared.Blinding and masking open label. Allocation ratio 1:1, Timing: 1 months, Intermittent assessment once at fifteenth day (i.e. baseline day zero, day 15 and day 30). Intervention (Drugs used for the trial will be GMP certified) Group A- 1 tablet Brahmi Vati (oral 250mg) at bed time (8:30 PM) Group B- 2 drops (~0.1 ml) Pratimarsha nasya of Brahmi ghrita at sunrise (early morning) in both nostrils alternatively (6 AM) Avoidance (Nidan Parivarjana) of stimulants tea/ coffee/smoking at evening/night, Alcoholic beverages, distractions like heavy food or plenty of liquid, exercise or evening Gym, Uncomfortable bed/mattress, mobile or other screen time gadgets after 8 PM (T.V., Tablet, laptop etc.), anxiety, fear etc. Life style modification – Shavasana for 10 minutes before bed time and left-hand side postural sleep throughout night. Assessment Criteria for study outcomes 1. Quantity of sleep (in Hrs) subjective as well as what’s app group monitoring of last seen or status seen timings as digital evidence (diary maintenance and log book maintenance and also encourage participants to use digital watch to measure duration of sleep as far as possible) 2. Quality of sleep – 1. PSQI (Pittsburgh sleep quality index) 2. Epworth sleepiness scale. SPARK/2024/3341/309 Other criteria parameters for study outcomes 1.Weight (in Kg) 2. BMI (Body mass index) Kg/m2 3. WHR (Waist hip ratio) Primary outcome: Change in quantity of sleep (in hours) Secondary outcome: Change in quality of sleep (PSQI, Epworth sleepiness scale.) • Trial will be started only after taking informed consent, IEC clearance and CTRI registration