| CTRI Number |
CTRI/2024/03/064094 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of ashwagandha churna in childhood insomnia(anidra) |
|
Scientific Title of Study
|
Evaluation Of ashwagandha churna in management of childhood insomnia (Anidra) –A randomized 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 Vinay Walunj |
| Designation |
PG Scholar |
| Affiliation |
KLE Shri BMK Ayurveda Mahavidyalaya,Belagavi |
| Address |
Department of kaumarabhritya
KLE Shri BMK Ayurveda Mahavidyalaya, Shahapur, Near Nath Pai circle, Belagavi, 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
09403976715 |
| Fax |
|
| Email |
vinaywalunj77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAziz Arbar |
| Designation |
HOD and professor |
| Affiliation |
KLE Shri BMK Ayurveda Mahavidyalaya,Belgavi |
| Address |
Department of kaumarabhritya
KLE Shri BMK Ayurveda Mahavidyalaya, Shahapur, Near Nath Pai circle, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAziz Arbar |
| Designation |
HOD and professor |
| Affiliation |
KLE Shri BMK Ayurveda Mahavidyalaya,Belgavi |
| Address |
Department of kaumarabhritya
KLE Shri BMK Ayurveda Mahavidyalaya, Shahapur, Near Nath Pai circle, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kle Ayurveda Hospital, Belagavi |
|
|
Primary Sponsor
|
| Name |
kle ayurveda hospital |
| Address |
KLE Shri BMK Ayurveda Mahavidyalaya, Shahapur, Near Nath Pai circle, Belagavi, 590003
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinay Walunj |
Kle Ayurveda Hospital |
OPD no 10, Department of Kaumarabhritya,KLE Shri BMK Ayurveda Mahavidyalaya, Shahapur, Near Nath Pai circle, Belagavi, 590003
Belgaum
KARNATAKA |
9403976715
vinaywalunj77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mamsyadi Ghana vati, Reference: Siddha yoga Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Churna, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sita and Ghrta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Age group 9-16 years of both genders
Children fulfilling the diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
Children with known case of sleep disorders like breathing related sleep disorder, pain conditions, urinary frequencies, asthma, malignancies, metabolic disorder etc.
Children with an acute or chronic, local or systemic infection will be excluded.
Children who are currently using other medications which may interfere with the outcome of the study will be excluded.
Children who have received any form of modern intervention for insomnia in last 2 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There might be significant effect of Ashwagandha churna in the management of childhood insomnia.
|
0th 15th 30th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PSQI- Pitsburgh sleep quality index- Quality & Patterns of sleep
Assessment of Anidra as per Ayurveda parameters |
0th 15th 30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Nidra (Sleep) being one of the Trayoupastambhas mentioned in Ayurveda; has uttermost importance in leading healthy and The prevalence of insomnia symptoms in girls is 16.3 % - 26.3% in age group of 9 -16 years and in boys age group of 9- 16 years the prevalence is 19%. Insomnia can also manifest as mood disturbance, irritability, emotional lability, depression, and anger; fatigue, increased somatic complaints, cognitive impairment, problem with memory, attention, concentration, decision- making, and problem solving, day time behaviour problems such as hyperactivity ,impulsivity, and noncompliance and academic problems, chronic tiredness.Medications are frequently prescribed, but there is a lack of data from controlled studies to support the use of pharmacologic agents in the management of childhood insomnia. Sedative of Benzodiazepines groups like Lorazepam, Alprazolam & Diazepam etc. on regular uses can cause severe withdrawal symptoms such as seizures, dependence & addiction. Hence there is a growing need for an alternative treatment modality.In Ayurveda there are several drugs which are known to be used for Anidra such as Ashwagandha and may be helpful in the management of childhood insomnia effectively. Therefore, this study is taken for the management of insomnia in children. |