| CTRI Number |
CTRI/2025/04/084890 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The comparative effect between Brahmivati and Brahmighrit on sleep in healthy adults of sleep deprivation. |
|
Scientific Title of Study
|
To evaluate and compare the effect Brahmivati(oral) and Brahmighrit (nasya) on sleep in nidranasha (Pimary Insomnia) as an adjuvant to sleep hygiene and Shavasana |
| 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 Neelam Gupta |
| Designation |
Associate professor and HOD |
| Affiliation |
A and U tibbia College and Hospital |
| Address |
Department of Rog Nidan
A and U Tibbia College and Hospital Karol Bagh New Delhi
Department of Rog Nidan
A and U Tibbia College and Hospital Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9307391212 |
| Fax |
|
| Email |
neelamsri08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Gupta |
| Designation |
Associate professor and HOD |
| Affiliation |
A and U tibbia College and Hospital |
| Address |
Department of Rog Nidan
A and U Tibbia College and Hospital Karol Bagh New Delhi
Department of Rog Nidan
A and U Tibbia College and Hospital Karol Bagh New Delhi
DELHI
110005
India |
| Phone |
9307391212 |
| Fax |
|
| Email |
neelamsri08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kritika Rai |
| Designation |
Student |
| Affiliation |
A and U tibbia Collegeand Hospital |
| Address |
A and U Tibbia College Karol Bagh New Delhi
A and U Tibbia College Karol Bagh New Delhi
North
DELHI
110005
India |
| Phone |
9205475795 |
| Fax |
|
| Email |
kritika88851@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College Karol Bagh New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,New Delhi-110005 |
| Type of Sponsor |
Government medical college |
|
|
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 NEELAM GUPTA |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Rog Nidan Ayurvedic and Unani Tibbia College and Hospital Karol Bagh
Central
DELHI |
9205475795
neelamsri08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee A and U Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Insomnia |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghrit, Reference: Ashtang Hridya Uttartantra, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi Vati, Reference: Charak Samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy adults (Assessed through validated Swasthya
Assessment scale with due permission) of Age 18-35 yrs of either sex willing to participate
with written informed consent of primary insomnia will only be enrolled for the present study |
|
| ExclusionCriteria |
| Details |
Non- Consenting and not apparently healthy adults and with secondary
insomnia (associated with other major systemic diseases) were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in quantity of sleep |
BASELINE - 15 DAYS [2 WEEKS] - ONE MONTH[4 WEEKS]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of sleep |
BASELINE - 15 DAYS[2 WEEKS] - ONE MONTH[4 WEEEKS] |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="15"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
METHODOLOGY: All the classical texts of ayurveda have been thoroughly reviewed to collect the matter related with approaches for the management of Nidranasha. PubMed etc. databases were searched for SPARK/2024/3341/309 articles published for the same by using key words strategy like Anidra, Nidranasha and primary insomnia and its management etc. The study will be conducted at the OPD/IPD patients & College students if found eligible at ‘X’ college and Hospital by developing a case record form (CRF), based purely on ayurvedic classical references and contemporary science evidences for pre and post subjective assessment of symptoms, quantity and quality of sleep etc.in apparently healthy adults of Primary insomnia. Since, not sufficient Ayurvedic researches are available on these drugs for Primary insomnia particularly, so as an exploratory research total 30 participants in 2 groups (A and B with 15 participants in each group). Randomization list will be prepared.Blinding and masking open label. Allocation ratio 1:1, Timing: 1 months, Intermittent assessment once at fifteenth day (i.e. baseline day zero, day 15 and day 30). Intervention (Drugs used for the trial will be GMP certified) Group A- 1 tablet Brahmi Vati (oral 250mg) at bed time (8:30 PM) Group B- 2 drops (~0.1 ml) Pratimarsha nasya of Brahmi ghrita at sunrise (early morning) in both nostrils alternatively (6 AM) Avoidance (Nidan Parivarjana) of stimulants tea/ coffee/smoking at evening/night, Alcoholic beverages, distractions like heavy food or plenty of liquid, exercise or evening Gym, Uncomfortable bed/mattress, mobile or other screen time gadgets after 8 PM (T.V., Tablet, laptop etc.), anxiety, fear etc. Life style modification – Shavasana for 10 minutes before bed time and left-hand side postural sleep throughout night. Assessment Criteria for study outcomes 1. Quantity of sleep (in Hrs) subjective as well as what’s app group monitoring of last seen or status seen timings as digital evidence (diary maintenance and log book maintenance and also encourage participants to use digital watch to measure duration of sleep as far as possible) 2. Quality of sleep – 1. PSQI (Pittsburgh sleep quality index) 2. Epworth sleepiness scale. SPARK/2024/3341/309 Other criteria parameters for study outcomes 1.Weight (in Kg) 2. BMI (Body mass index) Kg/m2 3. WHR (Waist hip ratio) Primary outcome: Change in quantity of sleep (in hours) Secondary outcome: Change in quality of sleep (PSQI, Epworth sleepiness scale.) • Trial will be started only after taking informed consent, IEC clearance and CTRI registration |