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Clinical Trials/CTRI/2023/08/057101
CTRI/2023/08/057101Not yet recruitingPhase 2/3

A Pharmaco Clinical Comparative Study Of Jatamansi (Nardostachys jatamansi DC.) and Ashwagandha (Withania somnifera Dunal) Moola Churna In The Management Of Anidra (Insomnia )

Government Ayurvedic College1 site in 1 country60 target enrollmentStarted: December 9, 2023Last updated:
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Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Subjective Parameter: Grading will be done with sign & symptoms of Anidra Hb TLC DLC SGOT/PT Serum Creatinine
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

In this trial we are selecting patients of Anidra in two groups, in which we will do intervention study of drug Ashawagandha mool choorana and jatamansi mool choorana in the form of capsule with the dose of 2 gm  OD at  night with luke warm water . Assessment will be done on the subjective parameters for anidra disease.

Route of administration: Oral

Follow up : Day 15, Day 30, Day 37

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with written consent.
  • •Patients having clinical features of Anidra as Angamarda, Shirogaurava, Jrambhika, Bhrama, Tandra, Jadyata.3) Patients with computer, mobile screening time less than 6 hours.

Exclusion Criteria

  • •Patients below the age of 18 Years and above the age of 60 years.
  • •pregnant and lactating mothers.
  • •Patients with history of any serious systemic illness hyper/hypo tension.
  • •patients taking medications like antidepressants, sleeping pills 5) Patients with computer, mobile screening time more than 6 hours.

Outcomes

Primary Outcomes

Subjective Parameter: Grading will be done with sign & symptoms of Anidra Hb TLC DLC SGOT/PT Serum Creatinine

Time Frame: At start of the trial and after 1 month of intervention of Ashwagandha powder & jatamansi powder, last follow up after 7 days of stopping medicine

Secondary Outcomes

  • Subjective Parameter Grading will be done with sign & symptoms of Anidra Hb TLC DLC(At start of the trial & after 1 month of intervention of Ashwagandha powder & jatamansi powder, last followup after 7 days of stopping the medicine.)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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