| CTRI Number |
CTRI/2022/07/043753 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on Passiflora Extract in tension and sleep problem |
|
Scientific Title of Study
|
A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective Clinical study to Evaluate Efficacy and Safety of Passiflora incarnata (Aerial Parts) Extract in participants with Stress and Insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PASSION/SI/JK/2022, Version 1.0, 2nd June 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra B Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College and Hospital Boradi, Tal. Shirpur, Dist. Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JK Botanicals Private Limited.
Jairamdass Khushiram Building,
Plot No: 5, Sector 19-C, Vashi,
Navi Mumbai-400 703. Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
JK Botanicals Private Limited |
| Address |
Jairamdass Khushiram Building,
Plot No: 5, Sector 19-C, Vashi,
Navi Mumbai-400 703. Maharashtra, India
|
| Type of Sponsor |
Other [Botanical Extract Manufacturer] |
|
|
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 Maheshkumar Harit |
D. Y. Patil University School of Ayurveda |
OPD No.10 Ground Floor, Department of Kayachiktsa,
Nerul, Sector 7 Navi Mumbai Mumbai (Suburban)
MAHARASHTRA-400706
Mumbai (Suburban)
MAHARASHTRA |
9322217607
drmaheshkharit@rediffmail.com |
| Dr Narendra B Mundhe |
KVTR Ayurvedic College and Hospital Boradi |
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule-425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, D. Y. Patil University School of Ayurveda, Nerul |
Approved |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, (2) ICD-10 Condition: Z733||Stress, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule containing Passiflora incarnata (Aerial Parts) Extract – 600 mg |
Dose and Duration: 1 capsule at bedtime for 30 days |
| Comparator Agent |
Placebo Capsule |
Dose and duration: 1 capsule at bedtime for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Literate subjects who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS)
2. Subjects with insomnia severity more than 7 and equal to 21 on insomnia severity index
3. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from any known chronic physical, hormonal or psychiatric illness
2. Subjects using oral or systemic contraceptive medications
3. Subjects with uncontrolled diabetes and hypertension
4. Subjects with substance dependence
5. Chronic alcoholics and Habitual Tobacco chewers.
6. Known cases of severe or chronic hepatic or renal disease.
7. Known case of any active malignancy.
8. Subjects giving history of significant cardiovascular event less than12 weeks prior to recruitment.
9. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
10. Known cases of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
11. Subjects using any other investigational drug within 1 month prior to recruitment or subjects currently participating in any other Clinical study
12. Known hypersensitivity to any of the ingredients used in study products
13. Pregnant and Lactating females.
14. Other conditions, which in the opinion of the investigators, make Subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in stress
2. Change in Patient-reported total sleep time
|
Screening visit, Day 0, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in general psychological health
2. Change in sleep efficiency
3. Change in Subject-reported time to sleep onset, patient- reported number of awakenings, patient -reported wake time after sleep onset
4. Change in severity of insomnia
5. Post study change in serum cortisol (morning) level
6. Change in daytime fatigue, daytime mood, ability to function at work, concentration and memory, quality of sleep
7. Assessment of requirement of rescue medications (sedatives)
8. Assessment of adverse events, vitals and safety lab parameters.
9. Global assessment for overall change by participants and by physician
|
Screening visit, Day 0, Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized, double blind, placebo controlled, multi-centric,
interventional, prospective clinical study to evaluate efficacy and safety of Passiflora incarnata (Aerial Parts) Extract in participants
with stress and insomnia. As per computer generated randomization list, participants will be
randomized either to Passiflora incarnata (Aerial Parts) Extract group or
placebo group in 1:1 ratio. Dose of Passiflora extract will be 600 mg at bed
time with water for 30 days. The primary objectives of the study will be to assess
stress and patient-reported total sleep time. The secondary objectives of the study will be
to assess general psychological health, sleep efficiency, subject-reported
time to sleep onset, patient- reported number of awakenings, patient -reported
wake time after sleep onset, severity of insomnia, serum cortisol (morning)
level, daytime fatigue, daytime mood, ability to function at work,
concentration and memory, quality of sleep, requirement of rescue medications
(sedatives), adverse events and vitals, safety lab parameters on screening
visit, day 0, day 15 and day 30 |