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

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]

·         Ashwagandha kwath at sukhoshan  body  temperature[ii]

·         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. 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.