| CTRI Number |
CTRI/2026/01/101546 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Ayurvedic managment in the Treatment of Insomnia. |
|
Scientific Title of Study
|
A randomised controlled clinical trial between clonazepam, ayurvedic polyherbal formulation, and shirodhara in the management of anidra (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 Nabanita Chakrabarty |
| Designation |
Assistant Professor ,Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Department of Kayachikitsa, Room no -1 Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,294 /3/1 A.P.C Road, Kolkata WEST BENGAL 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9432682951 |
| Fax |
|
| Email |
nabanita.newhope@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nabanita Chakrabarty |
| Designation |
Assistant Professor ,Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Department of Kayachikitsa, Room no -1 Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,294 /3/1 A.P.C Road, Kolkata WEST BENGAL 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9432682951 |
| Fax |
|
| Email |
nabanita.newhope@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Das |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Department of Kayachikitsa, Room no -1 Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,294 /3/1 A.P.C Road, Kolkata WEST BENGAL 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
7699249257 |
| Fax |
|
| Email |
ananyad978@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of West Bengal Department of Heath and Family Welfare Swasthya Bhawan GN 29 Sector V Salt Lake City Kolkata 700091. |
|
|
Primary Sponsor
|
| Name |
Government of West Bengal |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata
Kolkata WEST BENGAL 700009 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nabanita Chakrabarty |
Institute of Post Graduate Ayurvedic Education and Research At SVSP |
Department of Kayachikitsa, Institute of Post Graduate Ayurvedic Education and Research At SVSP Opd no.1 294/3/1 A.P.C Road, Kolkata -700009 Kolkata WEST BENGAL
Kolkata
WEST BENGAL |
9432682951
nabanita.newhope@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, IPGAE AND R KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F519||Sleep disorder not due to a substance or known physiological condition, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ayurvedic poly herbal Formulation, Reference: Tagara-200mg Jatamansi-200mg, Shankhapushpi-100mg, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | CLONAZEPAM 0.5 MG | | | 3 | Intervention Arm | Procedure | - | SiraHpicuH, शिरःपिचुः | (Procedure Reference: mUrdhatailam, Procedure details: Shirodhara is an Ayurvedic procedure where a stream of oil or herbal liquid(warm milk) is poured over the head for 45 to 90 minutes.)
(1) Medicine Name: Ayurvedic poly herbal Formulation, Reference: Tagara-200mg Jatamansi-200mg, Shankhapushpi-100mg, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: hs, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 to 60 years..
2. Diagnosed cases of Anidra (primary & secondary insomnia) based on Ayurvedic and modern criteria.
3. Patients with Insomnia Severity Index (ISI) score between mild to moderate (8-21).
4. Duration of insomnia greater than equal to 1 month and less than equal to 6 months.
5. Willing to participate and give written informed consent.
6. Patients able to comply with the study protocol and follow-up visits. |
|
| ExclusionCriteria |
| Details |
1.Patient below 18 years and above 60 years.
2.Patients with severe insomnia (ISI score greater than 21) requiring higher medical intervention.
3. History of substance abuse, alcohol dependence.
4. Pregnant or lactating women.
5. Patients with major chronic illnesses (e.g., uncontrolled diabetes, cardiac disease, renal or hepatic impairment). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality and duration (PSQI, ISI score reduction) |
At Baseline & after 1st weeks,2nd weeks and 4th weeks . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Absence of side effects
2. Improvement in patient-reported well-being
3. Reduction in anxiety & fatigue |
At Baseline ,1st weeks,2nd weeks, 4th weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
A RANDOMISED CONTROLLED CLINICAL TRIAL BETWEEN CLONAZEPAM, AYURVEDIC
POLYHERBAL FORMULATION AND SHIRODHARA IN THE MANAGEMENT OF ANIDRA (INSOMNIA). Anidra (Insomnia) is a prevalent sleep disorder that significantly impairs physical
health, mental well-being, and quality of life. Anidra (Insomnia) is described
in Ayurveda as a disorder resulting from the vitiation of Vata and Pitta doshas,
leading to impaired Nidra—one of the Trayopastambha essential for sustaining
life. In contemporary practice, insomnia is commonly managed with
benzodiazepines such as clonazepam; however, their long-term use is limited by
adverse effects, including dependence, tolerance, and cognitive impairment.
Ayurveda offers holistic, non-habit-forming therapeutic modalities through
Medhya and Nidrajanana herbs, along with Panchakarma procedures such as
Shirodhara. The present study is designed as a randomised, controlled,
open-label, three-arm clinical trial to evaluate and compare the efficacy and
safety of clonazepam, an Ayurvedic polyherbal formulation, and the combination
of the same formulation with Shirodhara in the management of Anidra. Ninety
diagnosed patients fulfilling the inclusion criteria will be randomly allocated
into three groups (n=30 each). Group A
will receive clonazepam (0.5 mg) at bedtime; Group B will receive an Ayurvedic polyherbal formulation containing
Tagara (Valeriana wallichii), Jatamansi (Nardostachys jatamansi), and
Shankhapushpi (Convolvulus pluricaulis)at bedtime; and Group C will receive the same formulation along with Shirodhara
using Kshira for 21 days. Clinical assessment will be carried out using validated
subjective parameters, namely the Pittsburgh Sleep Quality Index (PSQI) and
Insomnia Severity Index (ISI), along with sleep latency and sleep duration.
Data will be analysed using a paired t-test
for within-group comparison and one-way Analysis of Variance (ANOVA) followed
by post-hoc tests for intergroup comparison. A p-value
<0.05 will be considered statistically significant. The study is expected to establish Ayurvedic
interventions, particularly polyherbal formulation with Shirodhara, as
effective, safe, and sustainable alternatives to conventional pharmacotherapy
for Anidra. |