A Clinical Study of Anutailam Nasya compared with Bhramari Pranayama on Nidranasha i.e. Insomnia and Stress Anxiety and Depression in Adults.

Phase 2

• Conditions: Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhereHealth Condition 2: F439- Reaction to severe stress, unspecified

• Registration Number: CTRI/2020/08/027151
• Lead Sponsor: Dr Yogesh Bhagwanrao Shinde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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. ââ?¬Å?Ayurvedic Lakshanasââ?¬? 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. ââ?¬Å?Insomnia Severity Indexââ?¬? (ISI)

Patients scrutinized with ââ?¬Å?Insomnia Severity Indexââ?¬? (ISI),for inclusion of only ââ?¬Å?clinically significant casesââ?¬? of Insomnia, will only be selected.

5.ââ?¬Å?Insomnia Screening Questionnaireââ?¬? (ISQ)

Patients scrutinized with ââ?¬Å?Insomnia Screening Questionnaireââ?¬? (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.ââ?¬Å?Revised Classification of Adult Insomniaââ?¬?: (ICSD) i.e. International Classification of Sleep Disorders.

As per the ICSD Revised Classification of Adult Insomnia the patients of only ââ?¬Å?Secondary insomniaââ?¬?, 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. ââ?¬Å?Perceived Stress Scaleââ?¬?(PSS)

Insomnia patients scrutinized with ââ?¬Å?Perceived Stress Scaleââ?¬?(PSS), for the diagnosis of presence of perceived stress or not, will only be selected.

8. ââ?¬Å?Hamilton Anxiety Rating Scaleââ?¬?(HAM-A)

Patients scrutinized with ââ?¬Å?Hamilton Anxiety Rating Scaleââ?¬?(HAM-A), for the diagnosis of presence of Anxiety or not, will only be selected.

9.ââ?¬Å?Hamilton Depression Rating Scaleââ?¬?(HAM-D)

Patients scrutinized with ââ?¬Å?Hamilton Depression Rating Scaleââ?¬?(HAM-D), for the diagnosis of presence of Depression or not,will only be selected.

10.ââ?¬Å?Athens Insomnia Scaleââ?¬?(AIS)

As per the â

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 patientââ?¬•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified