| CTRI Number |
CTRI/2025/08/092523 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Find Out How Vibhitaki Capsules and Vacha Dhupana Therapy Help Improve Sleep in Working Women with Sleeplessness |
|
Scientific Title of Study
|
An Open Label Comparative Clinical Study To Evaluate The Effect Of Vibhitaki Phala MajjaTerminalia Belerica Capsule and Aromatherapy With Vacha Acrus Calamus Linn Dhupa in Working Women VisAVis Primary Insomnia |
| 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 Sughosh S Mujumdar |
| Designation |
M.D. Scholar (Manasaroga) |
| Affiliation |
Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi |
| Address |
OPD-3/OPD-7, Department of Manasaroga, Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8867752511 |
| Fax |
|
| Email |
sughosh.muj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra G Bhat |
| Designation |
B.A.M.S, MD (AYU) |
| Affiliation |
Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi |
| Address |
Department of Manasaroga, Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448139919 |
| Fax |
|
| Email |
ayurvijay25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sughosh S Mujumdar |
| Designation |
M.D. Scholar (Manasaroga) |
| Affiliation |
Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi |
| Address |
OPD3/OPD7, Department of Manasaroga, Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8867752511 |
| Fax |
|
| Email |
sughosh.muj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmashtala Manjunatheswara Ayurveda Pharmacy, Laxminarayana Nagar, P.O Kuthpady, Udupi, Karnataka, India - 574118 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Sughosh S Mujumdar |
Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi |
OPD3/OPD7, Department of Manasaroga, Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi.
Udupi
KARNATAKA |
8867752511
sughosh.muj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vibhitaki phala majja, Reference: Priya Vrat Sharma Classical uses of Medicinal Plants Chaukhambha Visvabharati 2004 p 334, Route: Oral, Dosage Form: Churna/ Powder, Dose: 400(mg), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vacha, Reference: Priya Vrat Sharma Classical uses of Medicinal Plants Chaukhambha Visvabharati 2004 p 334, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Dhupana |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Working women fulfilling diagnostic criteria of Insomnia as per DSM-5 and ICD-10.
2) Patients are selected of age group between 20-40years.
3) Patients willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from any systemic illness, psychiatric illness or disorder and
other metabolic disorders interfering with the treatment protocol.
2) Pregnant and lactating women.
3) Patient suffering from Substance abuse, Circadian rhythm disorder, Parasomnia. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment criteria:
Parameters will be scored by standard method and will be assessed before and after treatment on
0 th , 14 th and 28 th day and will be analysed statistically.
1) Athens insomnia scale
2) Insomnia severity index
3) Baseline values of Visual analogue scale (0-10) of Angamarda, Shirogourava, Jrumba,
Jaadya, Glani, Bhrama, Apakthi, Tandra compared with values of Visual analogue scale (0-
10) on 28 th day.
4) WHO Quality of life scale-Brief
Scored parameters will be analysed statistically after the treatment. All the subjective
parameters and scales will be assessed using Wilcoxon signed rank test within the groups and
Mann-Whitney U test in between the groups. |
observation will be made on 0th,14th and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
0th day and 28th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is Ramdomized open labelled parallel group study comparing the safety and efficacy of trial drug Group A - Vibhitaki phala majja capsule (400mg) 1 HS/ afterfood with warm water. Group B - Aroma-therapy with Vacha dhupa(5gm) once a day, 10min Before bed time. Dosage of Group A wiil be 400mg capsule at bed time and for group B Vacha dhupa for 10mins at bed time for 28 days for 15 patients to each group and will be conducted in Shri Dharmashtala Manjunatheswara College of Ayurveda, hosptial and research Centre,kuthpady, Udupi, Karnataka, India. The Primary majors will be assessed through Athens insomnia scale, Insomnia severity index and Baseline values of Visual analogue scale. The secondary outcome majors will be assessed based on the quality of life scale hence this study is an effort to prove the efficacy of Vibhitaki phala majja capsule and Aroma-therapy with Vacha dhupa in working women w.s.r primary insomnia.
|