| CTRI Number |
CTRI/2026/03/106301 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Polyherbal combination made from Brahmi, Shankhpushpi, and Vacha with Tagar powder in improving sleep in people suffering from insomnia. |
|
Scientific Title of Study
|
Effectiveness of a polyherbal churn formulation of Bramhi, Shankhpushpi and Vacha compared to Tagar churn in the management of Anidra (Primary insomnia):A Randomised Controlled Clinical Trial |
| 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 Nikita Gajanan Deulkar |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD 1, Kayachikitsa Department, Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9405950854 |
| Fax |
|
| Email |
nikitagdeulkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Dachewar |
| Designation |
HOD and Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD 1, Kayachikitsa Department, Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Gajanan Deulkar |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD 1, Kayachikitsa Department, Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9405950854 |
| Fax |
|
| Email |
nikitagdeulkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur 440024, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Gajanan Deulkar |
| Address |
OPD 1, Kayachikitsa Department, Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur 440024, Maharshtra, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Nikita Deulkar |
Shri Ayurved Mahavidyalaya, Nagpur |
OPD 1, Kayachikitsa Department, Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur.
Nagpur
MAHARASHTRA |
9405950854
nikitagdeulkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Ayurved Mahavidyalaya, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. 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, Reference: hmi - Dash B, SharmBraa RK. Charaka Samhita (Text with English Translation). Varanasi: Chowkhamba Sanskrit Series; 2001. Shankhpushi - 16) Nadkarni KM. Indian Materia Medica. Bombay: Popular Prakashan; 2009. Vacha- 20) Sharma PV. Dravyaguna Vijnana, Vol. 2. Varanasi: Chaukhamba Bharti Academy; 2003., Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: Polyherbal combination contains Brahmi Churna (1.875 gms),
Shankhapushi Churna (1.875 gms),
Vacha Churna(0.250 gms) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagar Churna, Reference: 24) Sharma PV. Dravyaguna Vigyan, Vol. II. 2nd ed. Varanasi: Chaukhambha Bharati Academy; 2006. p. 694-696., Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 and 60 years
2. Diagnosed cases of Primary Insomnia based on Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-IV)
3. AIS score more than or equal to 6 at baseline.
4. Duration of insomnia more than or equal to 1 month
5. Willingness to participate and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Secondary insomnia due to psychiatric disorders (e.g., depression, anxiety) or medical conditions.
History of substance abuse or sedative use within the past 2 weeks.
Severe hepatic, renal, or cardiovascular illness.
Pregnant or lactating women.
Known allergy to trial drugs or their components.
Known case of Lactose Intolerance.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study may provide improvement in sleep quality assessed by the Athens Insomnia Scale (AIS) score from baseline to after 30 days of treatment. |
At the end of 30 days (7th, 15th, 30th days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in severity of associated symptoms (Angamarda, Shirogaurava, Glani, and Jrumbha) before and after 30 days of treatment. |
At the end of 30 days (7th, 15th, 30th days) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
27/03/2026 |
| 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 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
|
This study will be carried out at OPD and IPD of Kayachikitsa Department of Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Nagpur. This is a double-blind randomized controlled trial aims at studying the comparison between polyherbal churna formulation of bramhi shankhpushpi and vacha with tagar churna in management of Anidra (primary insomnia.) A total of 80 patients will be included and will be randomly allocated to two treatment groups using Stratified block randomization method i.e. Group A and Group B each containing 40 patients. Group A will be trial group, where patients will receive polyherbal churna(bramhi , shankhapushpi and vacha )and Group B will be the control group, where patients will receive Tagar Churna. Then patients will be observed on 7th, 15th, and 30th day. All the findings will be recorded in case record form. At the end of trial, collected data will be analyzed and results will be drawn accordingly. |