| CTRI Number |
CTRI/2023/05/052263 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| 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 study to evaluate the efficacy of Aparajita Churna in Primary Insomnia. |
|
Scientific Title of Study
|
A Randomized open labelled controlled clinical study to evaluate the efficacy of Aparajita Churna in the management of Primary Insomnia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Stebin Anto |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5
Dept of PG Studies in Kayachikitsa
Sri Sri College of Ayurvedic Science and Research Hospital
21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8943150165 |
| Fax |
|
| Email |
stebinanto21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5
Dept of PG Studies in Kayachikitsa
Sri Sri College of Ayurvedic Science and Research Hospital
21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8147891325 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5
Dept of PG Studies in Kayachikitsa
Sri Sri College of Ayurvedic Science and Research Hospital
21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8147891325 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr. Stebin Anto |
| Address |
OPD No. 5
Dept of PG Studies in Kayachitsa
Sri Sri College of Ayurvedic Science and Research Hospital
21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore |
| 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 Stebin Anto |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
OPD No.5
Dept Of PG Studies in Kayachikitsa
Sri Sri College of Ayurvedic Science and Research Hospital
21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA |
8943150165
stebinanto21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aparajita Churna, Reference: BP.Guduchyadi Varga/111,112, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ksheera), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Churna, Reference: BP.Guduchyadi Varga/189,190, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ksheera), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between age group of 21-60 years of either gender.
Subjects fulfilling the diagnostic criteria of Primary Insomnia according to DSM 5.
Mild and moderate cases as per Insomnia severity index (score between 8-21)
Subjects willing to participate with written informed consent, which is conveyed
in the language which the subject can understand |
|
| ExclusionCriteria |
| Details |
Subjects on sleep inducing medications.
Subjects on drugs known to cause drowsiness.
Subjects on psychiatric treatments.
Subjects with insomnia secondary to pre-existing conditions like Schizophrenia,
mood disorders, BPAD, etc.
Pregnant and Lactating women.
Any other condition interfering the course of the disease and the intervention. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Insomnia Severity Index |
before intervention- 0th day
during intervention- 15th day
after intervention- 30th day
follow up- 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
25/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Insomnia is a condition of unsatisfactory quantity and/or quality of sleep,
which persists for a considerable period of time as per the International Classification
of Diseases with code ICD-10 F 51.0.
A study of general population in South India(2012), had found a prevalence of
18.6% for insomnia. There was increase in prevalence of Insomnia to 21% during
COVID-19 pandemic and lockdown as per surveys conducted in India in 2020.The
sleep related disorders though frequent, are under reported and their implications are
often neglected.
Primary insomnia refers to difficulty in initiating and maintaining sleep, not
related to other mental disorder or physical condition; it constitutes about 15% of
patients with chronic insomnia. The effects include fatigue or low energy, daytime
sleepiness, impaired attention, concentration, or memory, mood disturbance,
behavioral difficulties, impaired occupational or academic function, impaired
interpersonal or social function.
As per Ayurveda , Nidra is one among the Trayopasthambha (3 pillars of life)
and its proper observance is considered necessary for the maintenance of life, whereas
Nidranasha or Anidra (disturbed sleep) is said to cause various symptoms like
Angamarda, Gaurava, Alasya, Jrumbha, Jadya, Glani, Bhrama, Apakti, Tandra. The National Ayurveda Morbidity Code(NAMC) given for Anidra is RA-1,
which is closely related to Primary Insomnia.
In conventional system of medicine, sedatives, tranquilizers and psychotropic
drugs are generally used for sleep disorders, but they have also shown to develop
addiction and dependence in the patient on extended use. They may induce other
adverse effects like day- time sleepiness and CNS depression and also would have
hazardous withdrawal effect. Considering the prevalence, effects on productivity; adverse effects and
dependance on the contemporary interventions, it is highly relevant to search for a
safer, effective and economical solution to manage Primary insomnia with special
reference to Anidra.
Aparajita (Clitoria ternatea Linn.), mentioned by Acharya Bhavaprakasha in
Guduchyadi Varga is attributed with Sheeta virya , Tridoshahara, Medhya and
5
Rasayana property. Clitoria ternatea Linn. is also attributed with Anxiolytic,
Tranquilizing, Sedative, Anti-stress, Nootropic, Memory enhancer property. Hence,
taking the above background into consideration, it was thought worthwhile to evaluate
the efficacy of oral administration of Aparajita Churna in the management of Primary
Insomnia.
Whereas, Ashwagandha , mentioned by Acharya Bhavaprakasha in
Guduchyadi Varga being a proven drug for Primary Insomnia, is taken as a control
drug for the present study, in form of Churna.
|