| CTRI Number |
CTRI/2025/03/081500 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Primary Insomnia disease symptoms such as difficulty initiating or maintaining sleep, sleep interruption, reduction in sleep time, day time fatigue etc, using Ayurvedic formulations |
|
Scientific Title of Study
|
A single blind randomized controlled clinical study to evaluate the combined efficacy of Ksheerabala taila pichu with Mamsyadi kwatha and Sahadevi taila pichu with Simhimuladi kwatha in Anidra with special reference to 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 Ashwini Deshmukh |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Ashwini Deshmukh Dept of Kayachikitsa opd number 03 shri dgm ayurvedic medical college, Kalsapur road, shivanand nagar Gadag. 582103
Gadag
KARNATAKA
582103
India |
| Phone |
8861823715 |
| Fax |
|
| Email |
ashwinid903@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh N Belavadi |
| Designation |
Principal and Professor |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Dr Santosh N Belavadi Dept of Kayachikitsa opd number 03 shri dgm ayurvedic medical college, Kalsapur road, shivanand nagar Gadag. 582103
Gadag
KARNATAKA
582103
India |
| Phone |
9886916367 |
| Fax |
|
| Email |
hardikasnb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Deshmukh |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Ashwini Deshmukh Dept of Kayachikitsa opd number 03 shri dgm ayurvedic medical college, Kalsapur road, shivanand nagar Gadag. 582103
Gadag
KARNATAKA
581203
India |
| Phone |
8861823715 |
| Fax |
|
| Email |
ashwinid903@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri DGM Ayurvedic Medical College And Hospital Gadag. 582103 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Deshmukh |
| Address |
Shri DGM Ayurvedic Medical College And Hospital PG PhD Centre Kalsapur road,Shivanand nagar Gadag. 582103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini Deshmukh |
Shri DGM Ayurvedic Medical College PG Phd Centre and Hospital Gadag 582103 |
Dept of KayaChikitsa
OPD No 03
Gadag
Karnataka
Gadag
KARNATAKA |
8861823715
ashwinid903@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM Ayurvedic medical college ethical clearnce committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् | (Procedure Reference: Sushruta Samhita, Procedure details: A square piece of cotton cloth of the size 12 angula is soaked in sneha and placed over the head such as it does not leak. )
(1) Medicine Name: Sahadevi Taila, Reference: Shodala nighantu , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् | (Procedure Reference: Sushruta Samhita , Procedure details: A square piece of cotton cloth of the size 12 angula is soaked in sneha and placed over the head such as it does not leak.)
(1) Medicine Name: Ksheerabala Taila , Reference: Sahasrayoga Tailaprakarana , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects presents with symptoms like Jrumbha, Tandra, Angamarda, Klama, Shiroshula
and sign and symptoms of Primary Insomnia like difficulty initiating/maintaining sleep,
sleep interruption, reduction in sleep time, daytime fatigue since 1 month.
2.Subjects of age group 30-60 years.
3.Subjects of both genders.
4.Subjects fit for Pichukarma.
5.Subjects who willing to participate and gives written consent. |
|
| ExclusionCriteria |
| Details |
•Subjects with cancer, heart disease, asthma, gastroesophageal reflux disease, thyroid disease, parkinsons disease, alzheimers disease, sleep apnea and restless leg syndrome.
•Subjects with psychiatric illness like schizophrenia, major depressive disorder, psychosis, epilepsy and anxiety disorders.
•Subjects with chronic liver and kidney disorders.
•Subjects with diabetes and hypertension.
•Pregnant women and lactating women.
•Subject with alcohol dependency and drug dependence.
•Those who are working in night shifts.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of sign and symptoms like Jrumbha, Tandra,
Angamarda, Klama, Shiroshula of Anidra with special reference to Primary Insomnia. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the scores of Athens Insomnia Scale (AIS) |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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="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
|
Sleep has a restorative function and is important for conservation of energy and growth. In Ayurveda, Nidra is considered as an important component of Trayopastambha i.e Ahara,
Nidra, and Bramhacharya. This aphorism of Acharya Charaka shows the necessity of Nidra.
Acharya Charaka stated that happiness and misery, stoutness and thinness, strength and
debility, virility and impotence, knowledge and ignorance as well as life and death all are
depends on sleep. Persistent insomnia can leads to impairment of day time functioning, injury due to
accidents and the development of major depression. Insomnia is associated with substantial
impairment in an individuals quality of life. Various risk factors associated with increased
prevalence of chronic insomnia including older age, female gender and comorbid medical
and psychiatric conditions. Increasing age predisposes to sleep disorders (5% incidence in persons aged 30-50
years and 30% in those aged 50 years or older). people who are elderly experience a decrease
in total sleep time, with more frequent awakenings during night. Elderly persons also have
higher incidence. Hormonal variations during menstrual cycle or during menopause may
cause disruption in sleep. The surveys provide estimates of the prevalence of Insomnia based on insomnia
criteria as defined by the DSM (Diagnostic and Statistical Manual of Insomnia)-4 recognises
that about 1/3rd of general population presents at least one of them. When daytime
consequences of insomnia are taken into account, the prevalence is between 99% - 15%, 8
18% of general population are having sleep dissatisfactions. |