Ayurvedic medicine to get sleep

Not yet recruiting

• Conditions: Insomnia. Ayurveda Condition: अनिदà¥à¤°à¤¾,

• Registration Number: CTRI/2022/03/040953
• Lead Sponsor: Dr Girish Kale

Brief Summary

**TITLE OF DISSERTATION**

**“RANDOMIZED CONTROLLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWAGANDHA VATI WITHJATAMANASI VATI  IN THE MANAGEMENT OFNIDRANASHA W.R.T. INSOMNIAâ€**

**AIM ANDOBJECTIVES:**

 **Aim:**

ClinicalStudy To Evaluate The Efficacy Of Ashwagandha Vati With Jatamanasi Vati In TheManagement Of Nidranash w.r.t. Insomnia.

 **Objectives:**

•       To study theaetiopathogenesis of Nidranasha and correlate it with Ayurveda & Modernscience.

•       To evaluatethe efficacy of Ashwagandha Vati in the management of  Nidranasha w.r.t Insomnia.

•       To evaluatethe efficacy of Jatamanasi Vati in the management of  Nidranasha w.r.t Insomnia.

•       To comparethe efficacy of  Ashwagandha Vati withJatamanasi Vati In the Management of Nidranasha w.r.t Insomnia.

**RESEARCHQUESTIONS: -**

**PrimaryResearch Question: -**

Is Ashwagandha Vatiis effective in the management of Nidranash w.r.t Insomnia?

 **SecondaryResearch Question: -**

Isthe effect of Ashwagandha Vati is significant than Jatamanasi Vati in themanagement of Nidranasha w.r.t Insomnia?

 **HYPOTHESIS:**

 

**H0 :** Therewill be no significant effect of Ashwagandha Vati than Jatamanasi Vati inmanagement of  Nidranasha.

**H1 :** There will be significant effect of Ashwagandha Vati than JatamanasiVati in management of  Nidranasha.

**DIAGNOSTICCRITERIA:-**

1.Difficulty falling asleep, staying asleep ornonrestorative sleep.

2.Difficulty is present despite adequate opportunityand circumstance to sleep.

3.Impairment in sleep is associated with daytime impairment or distress.

4.Sleep difficulty occurs at least 3 times per week and has been a problem forat least 1 month.

 **METHOD OF COLLECTION OF DATA: -**

•       A proforma will be preparedwith details of History, physical examination, pathological investigations.

•       The general condition of thepatient, severity of symptoms before starting the treatment will be recordedproperly. The presenting symptoms will be observed on 0th day, 15th Day, 30thDay.

**SOP OF PREPARATION OF ASHWAGANDHA VATI:-**

Raw material for Ashwagandhawill be purchased from authentic pharmaceutical company. The authentication ofdrug will be performed from Department of Dravyaguna school of Ayurveda, NerulNavi Mumbai. The vati will be formed in the terms of tablets through authenticGMP certified company and the standardization of raw drugs and tablet formedwill be done from certified company.

The authentic rawAshwagandha will be taken followed by Pulverisation to make it into powder form.Starch, gum acacia will be added as Binder to make granules with binder.Further then the mixture form will allow to dry in a tray dryer. Eventually equalsize of granules will be prepare by granulator & tablet will be made bytablet punching machine.

**DOSE**: 1.5g (750mg 2 tablets at night)

**ANUPAN:**   Koshnajal (Warm Water)

**SOPOF PREPARATION OF JATAMANASI VATI:-**

Raw material for Jatamanasi will be purchased fromauthentic pharmaceutical company. The authentication of drug will be performedfrom Department of Dravyaguna school of Ayurveda, Nerul Navi Mumbai. The vatiwill be formed in the terms of tablets through authentic GMP certified companyand the standardization of raw drugs and tablet formed will be done fromcertified company. The authentic raw Jatamanasi will be taken followed byPulverisation to make it into powder form. Starch, gum acacia will be added as Binder to makegranules with binder. Further the mixture will allow to dry in a tray dryer.Eventually equal size of granules will be prepare by granulator & tabletwill be made by tablet punching machine.

**DOSE**: 1.5g (750mg 2 tablets at night)

**ANUPAN:**   Koshnajal (Warm Water)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients between age group 18 -70 years.
• Patients complaining of reduction in sleep time, difficulty in initiation of sleep, wakefulness during normal sleep 3.
• Either any of these or all of these for the duration of 1 months or more.
• Patients already diagnosed for Primary insomnia.
• Patient lying in between the range of 8-21 score as per the PSQI scale.

Exclusion Criteria

• Patient below 18 years and above 70 years.
• Pregnancy & Lactation.
• K/C/O any systemic Disorder 4.
• Patients with major psychiatric illness like schizophrenia, depressive psychosis, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in PITTSBURGH SLEEP QUALITY INDEX (PSQI) and Jrumbha, Angamarda, Tandra, Shirogaurav	Day 1, Day 15, Day 30

Trial Locations

Locations (1)

DY Patil School of Ayurveda; 🇮🇳 Thane, MAHARASHTRA, India

DY Patil School of Ayurveda

🇮🇳Thane, MAHARASHTRA, India

Dr Girish Kale

Principal investigator

9404477796

girishkale000.gk@gmail.com