Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere Health Condition 2: F439- Reaction to severe stress, unspecified
Conditions
Interventions
Intervention1: Anutailam Pratimarsha Nasya: Pratimarsha Nasya Nasal Instillation of 1 Bindu of Ayurvedic Medicinal Oil named Anutailam regularly in the evening period for 1 Month in Nidranasha specif
Sponsors
Dr Yogesh Bhagwanrao Shinde
Dr Milind Mohan Godbole
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age Criteria (WHO) : Patients in the adult age group i.e. between the age group of 20 and above up to 60 years irrespective of their gender, caste, religion and socioeconomic status. 2. Nidranasha (Insomnia) as an Ayurvedic symptom : Patients with the complaint of Nidranasha i.e. Insomnia as a general symptom. 3. “Ayurvedic Lakshanas ? Classical signs and symptoms as per Ayurveda) of Nidranasha Vyadhi (Insomnia disease) mentioned in the Ayurvedic Samhita i.e. Ashtang Sangraham. The classical symptoms of Nidranasha Vyadhi (Insomnia disease) ; namely amongst the Angamarda, Shirogourava, Jrumbha, Jadya, Glani, Bhrama, Apakti and Tandra; will be considered in the present study. Patients complaining of at least 3 Classical symptoms of Nidranasha Vyadhi (Insomnia Disease) amongst the above 8 symptoms, since at least three times a week from the duration of at least 1 month or more will be selected. Specifically, patients showing Angamarda, Shirogourava, Jrumbha, Jadya, Glani, Bhrama, Apakti or Tandra; as a symptom of Nidranasha disease, will only be selected. This will confirm the presence or absence of actual Nidranasha Vyadhi (Insomnia Disease) according to Ayurveda. 4. “Insomnia Severity Index ? (ISI) Patients scrutinized with “Insomnia Severity Index ? (ISI),for inclusion of only “clinically significant cases ? of Insomnia, will only be selected. 5.“Insomnia Screening Questionnaire ? (ISQ) Patients scrutinized with “Insomnia Screening Questionnaire ? (ISQ), for the differential diagnosis of a primary sleep disorder or secondary causes of insomnia. This means ISQ is used for the differential diagnosis of Insomnia, Psychiatric Disorders, Circadian Rhythm Disorder, Movement Disorders, Parasomnias or Sleep Disordered Breathing (Sleep Apnea, will only be selected. 6.“Revised Classification of Adult Insomnia ?: (ICSD) i.e. International Classification of Sleep Disorders. As per the ICSD Revised Classification of Adult Insomnia the patients of only “Secondary insomnia ?, including especially Adjustment insomnia i.e. stress induced insomnia or Inadequate sleep hygiene i.e. insomnia associated with lifestyle habits that impair sleep i.e. lifestyle related insomnia or Insomnia due to mental stress or Insomnia due to psychiatric disorders such as anxiety, or depression or Any of these from at least one month will be selected. Insomnia patients diagnosed with psychiatric disorders especially anxiety or depression & not started taking medication or treatments of any kind will only be selected. 7. “Perceived Stress Scale ?(PSS) Insomnia patients scrutinized with “Perceived Stress Scale ?(PSS), for the diagnosis of presence of perceived stress or not, will only be selected. 8. “Hamilton Anxiety Rating Scale ?(HAM-A) Patients scrutinized with “Hamilton Anxiety Rating Scale ?(HAM-A), for the diagnosis of presence of Anxiety or not, will only be selected. 9.“Hamilton Depression Rating Scale ?(HAM-D) Patients scrutinized with “Hamilton Depression Rating Scale ?(HAM-D), for the diagnosis of presence of Depression or not,will only be selected. 10.“Athens Insomnia Scale ?(AIS) As per the “Athens Insomnia Scale ?(AIS) patients complaining of either Reduction in sleep time or Difficulty in initiating sleep or Wakefulness during normal sleep or all o
Exclusion criteria
Exclusion criteria: 1. Patients with the complaint of Nidranasha or Insomnia with any other systemic or metabolic disorder. 2. Patients showing the complaints of like Angamarda,Shirogourava, Jrumbha, Jadya, Glani, Bhrama, Apakti or Tandra; independently as a separate disease or as a symptom of any other disease; will be excluded. 3. Patients of Primary Insomnia i.e. Idiopathic insomnia i.e. Insomnia arising in infancy or childhood with a persistent, unremitting course or Psychophysiologic insomnia i.e. Insomnia due to a maladaptive conditioned response in which patient associates the bed environment with heightened arousal rather than sleep; onset often associated with an event causing acute insomnia, with sleep disturbance persisting despite resolution of precipitating factor or Paradoxical insomnia (sleep-state misperception) i.e. Insomnia characterized by a marked mismatch between the patient’s description of sleep duration and objective polysomnographic findings. Patients with severe psychic disorders like schizophrenia, depressive psychosis, epilepsy etc. 4. Patients with any severe psychic disorders like schizophrenia, depressive psychosis, epilepsy etc. 5. Patients with Respiratory diseases e.g. Asthma, Bronchitis, and Sinusitis etc. which interfere with the Sleep or interfere with Nasya or Bhramari Pranayama will be excluded. 6. Patients with Physiological conditions like pregnancy, lactation and puerperal stage. 7. Patients with substance abuse or alcohol, drug or any other types of dependencies related with sleep. 8. Any condition or thing that requires waking up in the midnight.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome : Evaluation of the clinical effect of Anutailam Pratimarsha Nasya as compared to the clinical effect of Bhramari Pranayama, in the adult population, on 1. The ayurvedic symptoms of Nidranasha (Insomnia), 2. Additional Ayurvedic symptoms,and on 3. The signs and symptoms of Secondary Insomnia assessed as per the Athens Insomnia Scale, and 4. As per the Sleep Efficiency Index SEI).Timepoint: 1 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome : Evaluation of the clinical effect of Anutailam Pratimarsha Nasya as compared to the clinical effect of Bhramari Pranayama, in the adult population, 1. On lifestyle related anxiety assessed as per “Hamilton Anxiety Rating Scale ?, and 2. On depression assessed as per the “Hamilton Depression Rating Scale ? and 3. On perceived stress assessed as per “Perceived Stress Scale ?.Timepoint: 1 Month | — |
Countries
India
Contacts
Public ContactDr Yogesh Bhagwanrao Shinde
Maharashtra University of Health Sciences Nashik Maharashtra India
Outcome results
None listed