| CTRI Number |
CTRI/2023/02/049355 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
30/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of SDLSNT21 tablet in Patients of Nidranash(Insomnia). |
|
Scientific Title of Study
|
“A randomized double-blind controlled clinical study to evaluate the efficacy of SDLSNT21 in the management of Nidranash (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 Arpit Vankar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9537539855 |
| Fax |
|
| Email |
vankararpit666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9481328930 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinjin G Krishna |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
8921093277 |
| Fax |
|
| Email |
hridayapoorvam.rinjin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University |
|
|
Primary Sponsor
|
| Name |
Dean Faculty of Ayurved |
| Address |
Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Solumiks Herbaceuticals Limited |
135, Nanubhai Desai Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 400004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arpit Vankar |
Parul Ayurved Hospital |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia
391760
Vadodara
GUJARAT |
9537539855
vankararpit666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved -Institutional Ethics 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 | Other than Classical | | (1) Medicine Name: SDLSNT21, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Vati, Reference: API , Part 1, Volume 1, Monograph No.10 Ayurvedic Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having Classical Lakshana of Nidranash like Angamarda, Shirogaurava, Jrumbha, Jadyata, Glani, Bhrama, Apakti, Tandra.
2. Diagnosed case of insomnia made according to the guidelines mentioned in DSM-V for 3 month and above.
Patient ready to give inform consent and abide instruction.
|
|
| ExclusionCriteria |
| Details |
1 Patient below 20 years & after 60 years.
2 Insomnia secondary to Major mental disorders.
3 Pregnant and Lactating women.
4 Patient with RTA, Alcoholism.
5 Patient with drug dependency like anti-histamines and narcotics.
Patient with severe pain and orthopnea,
Uncontrolled DM & HTN.
Patient having chronic illness like IHD, COPD, Malignancies and other Medical conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment on the basis of gradation of classical symptomes of Nidranash. |
At baseline,on 15th day and on 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment on the basis of Pittsburgh Sleep Quality Index . |
At baseline,on 15th day and on 30th day. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Insomnia is the disorder of initiation and/or maintenance of sleep where patient is having difficulty in initiating of sleep, difficulty in maintening sleep ( Frequent awakenings during the night, Early morning awakening.),Non restorative sleep where despite an adequate duration of sleep, there is sleep pattern as well as loss of quality and quantity of sleep. Recent growth in digital media and smart phones has increased productivity expectations and blurred the line between work and personal life. All of these shortened free time, faster pace of life, and stress lead to sleep deprivation, which has serious implications for physical and mental health, job performance, and quality of life. |