Ashwagandha Kwatha Shiro Dhara in Insomnia

Phase 2

Not yet recruiting

• Conditions: Acute stress reaction, (2) ICD-10 Condition: F064||Anxiety disorder due to known physiological condition,

• Registration Number: CTRI/2020/07/026876

Brief Summary

****TITLE OF DISSERTATION** **:****

****A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF *JALADHARA ,*  *ASHWAGANDHA* *KWATHA*  *DHARA*  AND *TILA  TAILA  DHARA*  IN MANAGEMENT  OF  ANIDRA W.S.R  TO INSOMNIA****

**AIMS AND OBJECTIVES:**

1. To study and Evaluate the efficacy of *Jaladhara , Ashwagandha Kwath Dhara* and Tila Taila *Shirodhara*  in *Anidra* (INSOMNIA ) .

**MATERIALS AND METHODS:**

**Study design:** It is randomized, parallel, open label comparative clinical study.

Group A – *Jaladhra* is placebo control

Group B – *Ashwagandha kwath dhara* is intervention

Group C – *Tila taila dhara* is standard control

**SOURCE OF DATA:**

**a)****Literary source:**

All the classical, modern literatures and contemporary text including websites about the disease, drug and procedure will be reviewed and documented for the intended study.

**DRUG SOURCE** :

·         Tap water at sukhoshan body  temperature[[i]](#_edn1)

·         *Ashwagandha kwath* at sukhoshan  body  temperature[[ii]](#_edn2)

·         *Tila taila* at sukhoshan body temperature

**DRUG REVIEW** –

*Ushna jala* –it is *kapha* and  *vata rog hara* .

*Tila taila* is *Vata* *Kapha Hara* and isconsidered best for *Abhyanga and Avaghahan* .

*Ashwagandha*  *withania somnifera*  is *Vata Kapha Hara .  Ashwagandha* drug has potent anti stress activity . Root powder of *Ashwagandha* shown significant relief in anxiety neurosis[.](#_edn5) beside anti anxiety effect it shown reduction in plasma cortisol level and urinary catecholamine . The drug has an anti depressant and psychotropic activity.

*ASHWAGANDHA* KWATH PREPARATION – For 2000 ml of *Kwath* . 250 gm of *Ashwagandha Yava Kuta* *Churnam*  will be taken and its 16times of water  ie  4 ltrs . it would be reduced to 2ltrs  .

**b)** **SAMPLE SOURCE :**

Diagnosed Patients of *Anidra*  will be selected by Random Sampling procedure with respective of age 20 – 70 years, irrespective of sex, occupation, socioeconomic status from OPD, IPD and Special Camps in local area  conducted by All India Institue Of Ayurveda , sarita vihar , New Delhi -110076.

**METHOD OF COLLECTION OF DATA:**

**a)****Sample size:**

A minimum of 45  patients fulfilling the diagnostic criteria of either sex will

selected for the study.

 **c)****Diagnostic criteria:**

For diagnosis, detailed medical history with  physicalexamination and questionarrie will be done in  detail according to both modern andAyurvedic clinical method.  Patients diagnosed according to diagnostic scale AIS will be taken  .

**Inclusion criteria:**

1.       Patients presenting with complaints of Reduction of sleep time

2.       difficulty in initiation of sleep,Patients fulfilling ASI scoring i.e. greater than 6 or equals to 6 .

3.       Wakefulness during normal sleep.

4.       Either any of the above or all of them  for the duration of 3 months or more.

5.       Patient of either sex in the age group of 20 – 70  years.

**Exclusion criteria:**

1         Patient below 20 or above 70 years

2         Pregnant women and Lactating women.

3         Patient with Stroke, Hemorrhagic disorders, Epilepsy or any other serious psychotic disorder .

4         Patient with alcohol dependency or drug dependency will be excluded from study.

5         Subjects who all are awake at night due to  night shifts at working place.

SAMPLE SIZE - 45 total patients  , 15 in each group **Grouping:**

The selected patient will be randomly allocated into 3 groups , with 15  patients in each group .  I.e. Group A & GroupB and Group C . Group A will be administered *Jaladhara* , Group B will be administered *Ashwangandha Kwath Dhara* , and Group C will be administered *Tila Taila Shirodhara* .

RANDOMISATION – Block randomistaion method will be applied in this study .

**Interventions:**

**GROUP A - *JALADHARA***

Drug                      :  2000 ml freshtap water at sukhoshan temperature per day

Duration              : 30 min for  14 days

Assessment **:** Assessment will be done at end of 1st day, 4th day, 8th day, 12th day, 15th day, 22nd day, 30th day.

**GROUP B – *ASHWAGANDH AKWATH DHARA***

DRUG : 2000 ml freshly prepared kwath at sukhoshan temperature per day

Duration :  30min for 14 days

Assessment  â€“ assessment will be done at the end of 1st day ,4th day , 8th day, 12th day , 15th day , 22nd day ,  and 30th day .

**GROUP  C – *TILA TAILA SHIRODHARA***

DRUG : 2000 ml  TILA TAILA at sukhoshan  temperature per day

Duration :3o min  for 14  days

Assessment  : Assessment will be done at end of  1st day ,4th day ,8th day , 12th day ,  15th day ,22nd

and 30th day  .

 TOTAL DURATION OF STUDY : maximum of  30 days

  **PROCEDURE**

 ***POORVA KARMA***

*Purvakarma* is related with preparation of the patient and collecting materials required in *shirodhara*. Materials required are - *Shirodhara Yantra-*1,tap water at room temp. for *Dhara* , Gauze-1, Cotton earplugs-2, Soft pillow covered with rexin-1, Hot water bath-1, Vessels-3, Soft towels-2, Attendents-2.patient should be advised to pass stool and urine. Then patient pulse, temperature and blood pressure should be recorded.

**POSITION OF PATIENT**

Posture of the patient for *shirodhara* is supine position and *Dharapatra* should be fixed 4 *Angula* above the forehead. The eyes and ear should be covered with cotton to prevent the entry of liquid into eyes.

***PRADHAN  KARMA***

The room where *Shirodhara* is to be performed should be clean, well ventilated and very quiet. *Shirodhara* is done in the morning on empty stomach after proper massage. The selected liquid should be kept in the *Dharapatra* and poured continuously, neither very fast nor very slow on the centre of forehead of the patient in a single drip. During the procedure patient will be advised to concentrate on the point where drip is falling. The flow of the *jala/ kwath/ taila*  may be adjusted either with the help of stop cork or by putting small piece of cloth having knot at its inner end. The liquid is collected in another vessel and is used to refill the *Dharapatra* before it becomes empty.

**Duration:** This procedure is done for 30 mina day **.**

**Period for changing the liquid:**

*Jala  /  Ashwagandha  kwath*   will be  changed every day .

 **Temperature of liquid:**

Sukhoshan  temperature , which is comfortable and soothing  to the patient .

 ***Paschat karma*** **:**

After the *Dhara* process is completed, the head of the patient will  be wiped  and dried. This is followed by a short duration of rest. The patient will be advised to have a light diet.

**Assessment criteria:**

In 3 groups results of changes in signs and symptoms before and after treatment shall be observed and the same shall be recorded in the proforma of the case sheet prepared for the study.

**Subjective parameters:**

*1.*  *Jrimbha*

*2.* *Tandra*

*3.* *Angamarda*

*4.* *Angasada*

*5.* *Arti*

*6.* *Klama*

*7.* *Shirashoola*

*8.* *Shirojadhyata*

**Objective Parameter-**

1      Athens Insomnia scale (AIS)

**Statistical analysis**

For comparing the effect therapy between 3  groups statistical analysis will be done by following tests .

With in the group  -   Repeated Anova test

Between the group -   Anova

When non paramentric  -   Kruskal wallis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-20
• Study Start: 2020-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Patient presenting with complaints of reduction of sleep Difficulty in initiation of sleep Patient fulfilling ATHENS INSOMNIA SCORE scoring i.e. greater than 6 or equals to 6 Wakefulness during normal sleep Either any of the above symptoms or all of them for 3 months .

Exclusion Criteria

• 1Patient below 20 or above 70 years 2Pregnant women and Lactating women.
• 3Patient with Stroke, Hemorrhagic disorders, Epilepsy or any other serious psychotic disorder .
• 4Patient with alcohol dependency or drug dependency will be excluded from study.
• 5Subjects who all are awake at night due to night shifts at working place.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in ATHENS INSOMNIA SCALE	Assessment will be done on 1,4,8,12,15,22,30 day

Secondary Outcome Measures

Name	Time	Method
Reduction in following factors	1. Jrimbha

Trial Locations

Locations (1)

All India Institute Of Ayurveda; 🇮🇳 West, DELHI, India

All India Institute Of Ayurveda

🇮🇳West, DELHI, India

Dr Kavita Kumari

Principal investigator

8826127960

kavitasain757@gmail.com