| CTRI Number |
CTRI/2022/05/042597 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of the safety and efficacy of Ashwagandha whole plant extract in patients with insomnia. |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled comparative study to evaluate the safety and efficacy of Ashwagandha whole plant extract in patients with insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CW/107/ASH_INSM/I/JAN/22 Ver: 1.0 Date 07- March-2022. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena RM |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical College |
| Address |
BGS Global Institute of Medical Sciences
No 67, BGS Health and Education City,
Uttarahalli Road, Kengeri, Bengaluru - 560060
Bangalore
KARNATAKA
560060
India |
| Phone |
9880902005 |
| Fax |
|
| Email |
drveenarm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
Sami-Sabinsa Group limited |
| Address |
Sami-Sabinsa Group Limited
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.net |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
Sami-Sabinsa Group limited |
| Address |
Sami-Sabinsa Group Limited
19/1 & 19/2 â… Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.net |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore,
Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
SamiSabinsa Group Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore,
Karnataka, 560058. |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veena |
BGS Global Institute of Medical Sciences |
BGS Health and Education city, Uttarahalli Road,
Kengeri, Bangalore – 560060
Bangalore
KARNATAKA |
9880902005
drveenarm@gmail.com |
| Dr Chikkalingaiah Siddegowda |
Medstar Speciality Hospital |
No 641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore
Bangalore
KARNATAKA |
9844004187
drchikkalingaiahmedstar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
| Medstar Specialty Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One capsule, after dinner for 30days. |
| Intervention |
Withania somnifera (whole plant) extract 500 mg |
One capsule, after dinner for 30days. |
|
|
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 [DSM-IV-TR]
|
|
| ExclusionCriteria |
| Details |
1. Female who are pregnant, breast feeding or not willing to use adequate contraception during the course of the study.
2. BMI more than or equal to 18.5 or less than or equal to 35 kg/m2
3. Patient with psychiatric illness or concomitant disorder or any other condition that could potentially disturb or have impact on sleep.
4. Patients using tobacco products or caffeinated beverages during night awakenings.
5. Patient with diagnostic history of serious illness liver, kidney, heart, thyroid or bone marrow.
6. Patients on any medication for insomnia.
7. Patients with liver function parameters (total bilirubin, conjugated bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase) more than 2 times upper limit of normal.
8. Patients using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products.
9. Patients worked in night shifts within 5 days of screening or intended to do so during the course of the study.
10. Patients with history of alcohol abuse or drugs abuse.
11. Patients who were using any other medication that are known to influence sleep but could not be withdrawn.
12. Patients undergoing treatment for any other systemic illness.
13. Patients who are participated in another investigational drug had been used within three months prior to screening in this study.
14. Patients with known allergic reaction to the investigational product.
15. Patients who could not be relied upon to comply with the study procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in the Sleep Condition Indicator (SCI).
2. Mean change in total sleep time |
1. Day 0, Day 7 and Day 30.
2. Day 0, Day 7 and Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in average sleep latency per night
2. Mean change in average no of night-time awakenings per night.
3.Mean change in the salivary cortisol
4. Mean change in the WHO quality of life Questionnaire
5. Safety of Ashwagandha (whole plant) extract through changes in complete blood count (CBC); blood biochemistry test profile and occurrence of adverse events through the study period |
1. Day 0, Day 7 and Day 30
2. Day 0, Day 7 and Day 30
3. Day 0 and Day 30
4. Day 0 & Day 30
5. Day 0 to Day 30 |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All eligible patients who meet the Inclusion and Exclusion criteria will be enrolled in the study. All patients of this study will be randomised to either Ashwagandha 500 mg once a day or Placebo of 500mg once a day for a period of 30 days. 2 ml of saliva is taken in the morning (8:00 am) in a fasting state for salivary cortisol. Patient visits will be as follows on Screening Visit- visit 1(Day -5), Baseline -Visit 2 (Day 0), Visit 3 (Day 7) +/- 3 days; and Visit 4 (Day 30) +/- 5 days.
Telephonic follow-up after 10 days from the last visit to know the Adverse event and overall wellbeing of the patients. |