| CTRI Number |
CTRI/2025/01/078942 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on HTGF-122105 Capsule in participants with sleeplessness |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Multicentric, Placebo-Controlled Clinical Study to Evaluate Efficacy & Safety of HTGF-122105 in Primary Insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/058/2024, Version 1.0, 20th Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Shinde |
| Designation |
Consultant Physician General Medicine |
| Affiliation |
Shivam Multispecialty and Accident Care Centre Pvt Ltd |
| Address |
Medicine Department Ground Floor OPD no 10 Shivam Multispecialty and Accident Care Centre Pvt Ltd Opp Riverview City Solapur Pune Hwy Haveli Taravadi Phursungi Pune
Pune
MAHARASHTRA
412308
India |
| Phone |
9763332545 |
| Fax |
|
| Email |
drsandeep112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head Medical services and Clinical Development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Makali Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549904 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.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 Centre Ramchandra Lane Extension Kachpada Malad West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company (HWC)
Makali, Bengaluru 562 162,
India
|
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company (HWC) |
| Address |
Makali, Bengaluru 562 162,
India
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Kamlakar Ghaisas |
Ayurved Seva Sangh Ayurved Mahavidyalaya |
Department of General Medicine, Ground Floor OPD No. 14, Ganeshwadi, Panchvati, Nashik 422003
Nashik
MAHARASHTRA |
8275815966
nitin.ghaisas@gmail.com |
| Dr Chetan Dilip Vispute |
D Y Patil Medical College |
Department of Psychiatry, Psychiatry OPD. Ground Floor.
D Y Patil Medical College, Nerul. Navi Mumbai – 410209
Mumbai (Suburban)
MAHARASHTRA |
9664477488
cdvispute@gmail.com |
| Dr Rahul Patil |
Nirvikar Ayurveda Hospital |
Department of General OPD,
OPD No. 1, First Floor, Nirvikar Ayurveda Hospital, B Wing, Jay Ganesh Samrajya, Nashik Hwy, Sector No. 3, Bhosari, Pune, 411039
Pune
MAHARASHTRA |
9561912974
drrahul2886@gmail.com |
| Dr Sandeep Shinde |
Shivam Multispecialty and Accident Care Centre Pvt Ltd |
Medicine Department Ground Floor OPD no 10 Shivam Multispecialty and Accident Care Centre Pvt Ltd Opp Riverview City Solapur Pune Hwy Haveli Taravadi Phursungi Pune 412308
Pune
MAHARASHTRA |
9763332545
drsandeep112@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethcis Committee, D Y Patil Medical College, Nerul. Navi Mumbai |
Approved |
| Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik. |
Approved |
| Institutional Ethics Committee, Dr. Mhaske Hospital and Research Centre Pvt. Ltd., Hadapsar, Pune |
Approved |
| Institutional Ethics Committee, Nirvikar Ayurved Hoapital, Bhosari, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: HTGF-122105 capsules, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(NA), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 56 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: 2 capsules at bed time daily with water for 56 days | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Capsules | 2 capsules at bedtime daily with water for 56 days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with a) difficulty in initiating sleep, b) staying asleep or waking up early in the morning c) for at least for 3 nights per week d) for at least last 1 month and e) Insomnia with significant distress and persistent preoccupation with deficiency of sleep
2. Subjects willing to sign inform consent form
3. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
|
|
| ExclusionCriteria |
| Details |
1. History or diagnosis of any other physical, psychological or psychosomatic (including neurological) sleep disorder
2. Subjects with ongoing medications that may be considered contributory to insomnia like psychostimulants, amphetamines, cold medicines, decongestants (like oxymetazoline), beta-agonist, theophylline, caffeine, and any other as determined by the investigator.
3. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids like prednisone, opioid pain relievers, hypnotics and or prescribed other regular sleep medication.
4. History of bipolar disorder, psychotic disorder including depression and generalized anxiety disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
5. History of substance abuse or dependence
6. Subjects with habit of smoking Cigarette (more than 10 cigarette per day)
7. Subjects with known history of Hepatitis B and or C
8. History of malignancy less than or 5 years prior to signing informed consent
9. Known hypersensitivity to any of the ingredients (Tagara etc.) of study product
10. Other conditions, which in the opinion of the investigators, makes the
subject unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change in sleep parameters (Total sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Average resting heart rate, Average resting respiration rate through Actigraphy
2) Change in Sleep parameters (Total sleep time, no of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Time to get up after wake up, overall Sleep Quality) through sleep diary
|
Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in stress as assessed using Stress Mindset Measure (SMM)
2. Change in insomnia-related daytime functioning (daytime sleepiness, tiredness, mood disturbances, irritability) on graded scale in natural setting
3. Change in fatigue on VAS
4. Global assessment for overall change by investigator and by subject
5. Assessment of tolerability of study product by assessing adverse events and Adverse drug reactions
6. Safety of study product through clinical & laboratory assessment (Hematology (CBC), SGOT, Sr. Creatinine, Blood Sugar).
7. Safety evaluation through assessment of adverse events
8. Proportion of subjects withdrawing from the study because of adverse events (tolerability).
|
Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It
is a randomized, double-blind, multicentric, placebo-controlled clinical study
to evaluate efficacy & safety of HTGF-122105 in primary insomnia. The study
will be conducted in 4 centers in India. As per computer generated randomization
list, subjects will be randomized to either HTGF-122105 capsule group or
similar looking placebo group in 1:1 ratio. Subjects will be asked to take
given product in a dose of 2 capsule at bedtime daily with water for 56 days.
The primary objectives will be to assess change in sleep parameters (Total
sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total
duration of awakenings (WASO), Sleep efficiency, Average resting heart rate,
Average resting respiration rate through Actigraphy and change in Sleep parameters (Total sleep
time, no of awakenings, Total duration of awakenings (WASO), Sleep efficiency,
Time to get up after wake up, overall Sleep Quality) through sleep diary.
The
secondary objectives of the study will be to assess change in stress as
assessed using Stress Mindset Measure (SMM), change in insomnia-related daytime
functioning (daytime sleepiness, tiredness, mood disturbances, irritability) on
graded scale in natural setting, change in fatigue on VAS, global assessment
for overall change by investigator and by subject, tolerability of study
product.
Safety of study
product assessed through clinical & laboratory assessment (Haematology
(CBC), SGOT, Sr. Creatinine, Blood Sugar), and reporting adverse events, and
proportion of subjects withdrawing from the study because of adverse events
(tolerability) on screening Visit/ Baseline visit (intervention free period),
Day 28, Day 56. |