| CTRI Number |
CTRI/2024/09/073278 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Efficacy of Ayurvedic Formulation INS 00l in Treating Insomnia |
|
Scientific Title of Study
|
To determine the efficacy of an Ayurvedic formulation INS00l in treating Insomnia disorder A
pilot feasibility study |
| 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 Yogeshwar Chippa |
| Designation |
Ayurveda Research Scientist |
| Affiliation |
Sri Sri Institue of Advanced Research |
| Address |
Room no 3 Dept of Ayurveda Sri Sri Institue of Advanced Research. 21st KM kanakapura road Bangalore Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9975264201 |
| Fax |
|
| Email |
yogeshwar.chippa@ssiar.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeshwar Chippa |
| Designation |
Ayurveda Research Scientist |
| Affiliation |
Sri Sri Institue of Advanced Research |
| Address |
Room no 3 Dept of Ayurveda Sri Sri Institue of Advanced Research. 21st KM kanakapura road Bangalore Karnataka
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9975264201 |
| Fax |
|
| Email |
yogeshwar.chippa@ssiar.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogeshwar Chippa |
| Designation |
Ayurveda Research Scientist |
| Affiliation |
Sri Sri Institue of Advanced Research |
| Address |
Room no 3 Dept of Ayurveda Sri Sri Institue of Advanced Research. 21st KM kanakapura road Bangalore Karnataka
KARNATAKA
560082
India |
| Phone |
9975264201 |
| Fax |
|
| Email |
yogeshwar.chippa@ssiar.org |
|
|
Source of Monetary or Material Support
|
| Sri Sri Institute for advanced research (SSIAR)
Room no 3 Dept of Ayurveda
Sri Sri Institue of Advanced Research.
21st KM kanakapura road Bangalore Karnataka
560082 |
|
|
Primary Sponsor
|
| Name |
Sri Sri Institute for advanced research SSIAR |
| Address |
Ved Vignan Maha Vidya Peeth, 21st Km Kanakapura Rd,Udayapura, Bengaluru, Karnataka 560082 |
| Type of Sponsor |
Research institution |
|
|
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 Yogeshwar Chippa |
Sri Sri Institute for Advanced Research |
Room no 3.
Dept of Ayurveda,
SSIAR.
21st KM kanakapura road Bangalore
Karnataka 560082
Bangalore Rural
KARNATAKA |
9975264201
yogeshwar.chippa@ssiar.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institute for advanced research (SSIAR) |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tab INS001, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female participant above 18 to 60 years of age and willing to give written inform Consent.
2.Perceived total sleep time of more than 6 hours per night
3.Patient with history of self-reported primary insomnia or with diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV. |
|
| ExclusionCriteria |
| Details |
1.Female who are pregnant, breast feeding or not
willing to use adequate contraception during the
course of the study.
2.Patient with psychiatric illness or concomitant
disorder or any other condition that could
potentially disturb or have impact on sleep.
3.Patients using tobacco products or caffeinated
beverages during night awakenings.
4.Patients on any medication for insomnia.
5.Patients using any sedative hypnotic drugs
including benzodiazepines, non-benzodiazepine
synthetic drugs, herbal and OTC products.
6.Patients working in night shifts within 5 days
of screening or intended to do so during the
course of the study.
7.Patients with history of alcohol abuse or drugs
abuse.
8.Patients who were using any other medication
that are known to influence sleep but could not be
withdrawn.
9.Patients who are participated in another
investigational drug had been used within three
months prior to screening in this study.
10.Patients who could not be relied upon to
comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Sleep duration and Sleep quality. |
Day0,Day15,Day30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sleep quality of individuals under Ayurveda medication. |
Day0,Day15,Day30. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
21/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Insomnia is a major public health problem and sleep disturbance is most common in both adults and children. It is the difficulty in initiating and maintaining sleep or both, or the perception of poor sleep quality, in which the patient’s physical,psychological and social activities are interfered with, by a strong feeling of sleep deficiency upon waking in the morning.Insomnia is one among the 7 categories of sleep disorders in the International Classification of Sleep Disorders-3 (ICSD-3(2020). In Ayurveda, Nidra has been given prime importance and hence included in the tripods of life. So alteration in the natural process of nidra has a huge impact on the life processes as well. These alterations include nidranasa (complete loss of sleep), alpanidra (partial loss of sleep), nidradhikya (excess sleep) etc.Nidranasa, alpanidra, nidradhikya are vata, pitta, kapha nanatmaja vyadhis respectively. The expected outcomes are to evaluate the efficacy of Tablet INS001 in patients suffering from Insomnia and to evaluate the sleep quality of individuals under Ayurveda medication. The outcome measure would be the psychometric assessment of sleep quality using PSQI comparing Pre vs Post intervention. |