CTRI

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CTRI Number

CTRI/2026/02/102861 [Registered on: 03/02/2026] Trial Registered Prospectively

Last Modified On:

31/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Effect of Polyherbal combination A K Vati in Nidranasha

Scientific Title of Study

Prospective Single Arm Open Clinical Trial To Study The Efficacy Of Polyherbal Combination A K Vati In Anidra With Special Reference To Stress Induced Insomnia

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Akanksha Dnyandeo Kadam
Designation	PG Scholar
Affiliation	Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara
Address	PG Department of kayachikitsa Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM Gendamal Satara MAHARASHTRA Satara MAHARASHTRA 415002 India
Phone	8080027386
Fax
Email	dnyandeoakanksha@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sameer Pralhad Shinde
Designation	Associate Professor
Affiliation	Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalya,Satara
Address	PG Department of kayachikitsa Cabin no 2 Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM Gendamal Satara MAHARASHTRA Satara MAHARASHTRA 415002 India
Phone	7507043414
Fax
Email	sameershubha85@gmail.com

Details of Contact Person
Public Query

Name	Dr Akanksha Dnyandeo Kadam
Designation	PG Scholar
Affiliation	Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara
Address	PG Department Of kayachikitsa Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM Gendamal Satara MAHARASHTRA Satara MAHARASHTRA 415002 India
Phone	8080027386
Fax
Email	dnyandeoakanksha@gmail.com

Source of Monetary or Material Support

nil

Primary Sponsor

Name	Dr Akanksha Dnyandeo Kadam
Address	PG Department Of kayachikitsa SCM AVM Gendamal Satara 415002 MAHARASHTRA
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Akanksha Dnyandeo Kadam	sheth chandanmal mutha aryangla vaidyak mahavidyalaya satara	Room no 4 OPD block department of kayachikitsa dr m n Agashe aryngla hospital satara Satara MAHARASHTRA	8080027386 dnyandeoakanksha@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee SCM Aryangla Vaidyak Mahavidyalaya Satara	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:F489\|\|Nonpsychotic mental disorder, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Polyherbal Combination A K Vati, Reference: Harityakyadi Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna Dugdh), Additional Information:

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Individuals between the age group of 18 to 80 years of both sexes having stress induced insomnia of minimum one month duration selected randomly for study patients of insomina with HTN depression and anxiety disorder without any complications of any othe diseases

ExclusionCriteria

Details

Patients below 18 years and above 80 years of age
Patients with major psychiatric illness like schizophrenia depressive psychosis epilepsy etc were not registered.
Patients having chronic illness like asthma malignancies liver cirrhosis chronic renal failure diabetes etc were excluded
Patients with acute illness like cardiovascular accidents congestive cardiac failure myocardial infarction chronic obstructive pulmonary disorders meningitis acute pain conditions and similar other disorders were excluded.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To Evaluate the efficacy of A K Vati in Anidra	7th 14th 21st day

Secondary Outcome

Outcome	TimePoints
To evaluate any adverse effect of Polyherbal Combination A K Vati in Andira If Any	7th 14th and 21st day

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

15/03/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [dnyandeoakanksha@gmail.com].

For how long will this data be available start date provided 15-03-2028 and end date provided 15-03-2033?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil

Brief Summary

This current clinical trial is Single arm open clinical trial

This study is being conducted to evaluate the efficacy of polyherbal combination A. K. Vati in management of Anidra with special reference to Stress Induced Insomnia

After screening the patients at OPD and IPD level 60 patients will be selected for trial, informed written consent will be taken in native language

Insomnia (Inadequate quality and quantity of sleep) may be a symptom of stressful lifestyle, depressive illness, anxiety disorders, any psychiatric conditions or any other pathologic conditions. Whatever may be the cause of insomnia it needs immediate attention in present day lifestyle. It is affecting nearly 1/3rd of population (especially youth) in western developed countries and the incidence are increasing day by day in the developing countries like India, Nepal, Sri Lanka, Bangladesh etc. If insomnia is left untreated, it may reduce mental capacity of an individual, reduce efficacy, increase the chances of various types of accident and ultimately it may drag the individual towards several severe psychosomatic disorders.

Null Hypothesis

A. K. Vati 1000 mg orally at bedtime for 21 Days is not effective in Anidra with special reference to Stress Induced Insomnia

Alternative Hypothesis

A. K.Vati 1000 mg orally at bedtime for 21 Days is effective in Anidra with special reference to Stress Induced Insomnia

Drug - Polyherbal combination A.K. Vati

Dose - 1000 mg at bedtime

Anupana - Koshna Dugdha

Sevana Kala - At bedtime

Duration - 21 Days

Follow up - 7th , 14 th and 21st Day