A randomized control trial to evaluate the efficacy between Jatamansi Taila Shirodhara with Bala and Shatavari Siddha Ksheera Shirodhara in Insomnia (Anidra)

Introduction:

In Ayurveda, Anidra is described as a symptom, a disease, and sometimes even a complication. According to Acharya Charak, manifestations of Anidra include yawning, body ache, drowsiness, head disorders, heaviness in the eyes and head, laziness, giddiness, indigestion, stupor, and diseases caused by aggravated Vata10.

Insomnia usually manifests as difficulty in falling asleep or maintaining sleep11. It can be considered both a disease and a symptom of underlying diseases such as asthma, malignancy, cirrhosis and chronic liver failure. Depending on its duration, insomnia can be classified as acute or chronic. Acute insomnia lasts less than a month, while chronic insomnia lasts a month or more12**.**

In modern medicine, the treatment of insomnia often involves the use of and sedatives and hypnotics which can lead to drug addiction and have negative effects on health. In Ayurveda, many clinical trials and studies have been conducted on the management of Anidra, and significant results have been achieved with Shirodhara. This clinical study aims to compare the effects of Shirodhara with Jatamansi Siddha Taila and Bala Shatavari Siddha Ksheera on patients with Anidra.

RESEARCH QUESTION:

Is Jatamansi Siddha TailaShirodhara more effective than Bala Shatavari Siddha Ksheera Shirodhara in Anidra?

**HYPOTHESIS:**Jatamansi Siddha Taila Shirodhara is more effective than Bala Shatavari Siddha Ksheera Shirodharain Anidra.

*NULL HYPOTHESIS:Jatamansi Siddha Taila Shirodharadoes not have better efficacy than Bala and *ShatavariSiddha Ksheera Shirodhara in the management of Anidra

**ALTERNATE HYPOTHESIS:**Shirodhara with Jatamansi Siddha Taila and Bala and Shatavari Siddha Ksheera is equally effective in the management of Anidra

OUTCOME:

Jatamansi Siddha Taila Shirodhara may or may not show better efficacy  than Bala Shatavari Siddha Ksheera Shirodhara in the management of Anidra(Insomnia)

Aim and****Objectives:

Aim

To evaluate the effect of Jatamansi Siddha Taila Shirodhara in the management of Anidra in comparison to Bala Shatavari Siddha Ksheera Shirodhara.

Objectives:*1.*To evaluate the effect of Jatamansi Siddha TailaShirodharain Anidra

(Insomnia).

2.     To evaluate and compare the effect of Jatamansi Siddha TailShirodharaand Bala Shatavari Siddha Ksheera Shirodharain Anidra.

Materials and methods•       **Study design                          -**Randomized control clinical trial

•         **Study population                  -**Patients diagnosed with *Anidra (*Insomnia) fulfilling the inclusion criteria will be selected from OPD and IPD of Panchakarma Department CBPACS, New Delhi.

•    Study setting-           OPD and IPD of panchakarma department of CBPACS, New Delhi.

•    **Sample size                              -**90(45 in each group)

•    Study period including

**Follow up                                -**30 days

**Method of Simple Randomization-**Computer Generated Random Numbers

DIAGNOSTIC CRITERIA

·       A predominant complaint of dissatisfaction with sleep quantity or quality, associated  with one (or more) of the following symptoms:

1.     Difficulty in initiating sleep.(In children, this may manifest as difficulty initiating sleep without caregiver intervention.)

2.     Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)

3.     Early-morning awakening with inability to return to sleep.

4.     The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioural, or other important areas of functioning.

·       The sleep difficulty occurs at least 3 nights per week.

·      The sleep difficulty is present for at least 3 months.

·      The sleep difficulty occurs despite adequate opportunity for sleep.

·      The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).

·      The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).

·      Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.

 Inclusion****Criteria

1.Patients diagnosed with Insomnia according to DSM-5-TR29

2.  Age group 16 to 50 years.

3.Patients of insomnia with hypertension and anxiety disorders without complications   of any other systematicdiseases.

 Exclusion Criteria1. Having major psychiatric illness like schizophrenia, Alzheimer’s, Brain tumor and uncontrolled hypertension.

2. With alcohol dependency.

3.Patients of asthma, malignancies, liver cirrhosis, chronic renal failure.

4.Patients of any acute illness.

Withdrawal Criteriaa)  Patients willing to quit in between study will be allowed to quit and will be replaced.

b)  If any co morbidities develop than patient will be excluded.

Investigations:The entire patients were subjected to routine investigations to rule out any complications.

1. Blood investigations: Hb, TLC< DLC< ESR

2. Urine investigations: routine and microscopic examination

3. Stool Investigations: routine and microscopic examinations

Calculated by online open epi open-source calculator using mean difference formula. RCT: Equivalence of two means.

N= (Z1-α + Z1-β)2 [V1 + V2]

[d-(m1-m2)]2

Z1-α: Value of normal deviate at considered level of confidence (one sided)

Z1-β: Value of normal deviate at considered power of study

m1: Anticipated mean of the variable in the standard treatment group

m2: Anticipated mean of the variable in the new treatment group

V1: Anticipated variance of the variable in the standard treatment group

V2: Anticipated variance of the variable in new treatment group

d: considered maximum difference between means within which one group is considered to be non-inferior to the other

The standard deviation () has been taken from an earlier study on the ‘Effect of

Bala Shatavari Siddha Ksheera Shirodharaand Tila Taila Shirodhara in Anidra’.

Mean difference of 0.206 is used on the basis of difference in the parameter “Current sleep (Satisfied/Dissatisfied).

Z1-α-95%, Z1-β-80%, m1-0.696, m2-0.49, v1-0.337, v2-0.337

N=90(45in each group)