| CTRI Number |
CTRI/2025/01/079596 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurveda treatment in Insomnia. |
|
Scientific Title of Study
|
Evaluation of Taila Dhara on Nidranasha (Insomnia) by Polysomnography A Randomized Clinical Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAYANK TRIKHA |
| Designation |
2nd Year PG Scholar Department of Panchakarma |
| Affiliation |
KAHERs Shri B M K Ayurved Mahavidyalaya |
| Address |
Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda
Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9877238471 |
| Fax |
|
| Email |
mayanktrikha28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VISHWANATH S WASEDAR |
| Designation |
Associate Professor, Department of Panchakarma |
| Affiliation |
KAHERs Shri BMK Ayurved Mahavidyalaya |
| Address |
Department Of Panchakarma KAHERs Shri BMK Ayurveda
Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
8494946898 |
| Fax |
|
| Email |
drvswayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHWANATH S WASEDAR |
| Designation |
Associate Professor, Department of Panchakarma |
| Affiliation |
KAHERs Shri BMK Ayurved Mahavidyalaya |
| Address |
Department Of Panchakarma KAHERs Shri BMK Ayurveda
Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
8494946898 |
| Fax |
|
| Email |
drvswayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kaher Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
DR. MAYANK TRIKHA |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Karnataka India 590003
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayank Trikha |
KLE Ayurveda Hospital and Medical Research Centre |
OPD No. 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi 590003
Belgaum
KARNATAKA |
9877238471
mayanktrikha28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KLE Universitys Shri B. M. Kankanwadi Ayurved Mahavidyalya & KLE Ayurved Hospital, Shahapur, Belagavi |
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 | - | tailadhArA, तैलधारा | (Procedure Reference: Astanga Hrudaya , Procedure details: Taila Dhaara with Murchita tila taila for 30 minutes for 7 days externally ))
| | 2 | Comparator Arm (Non Ayurveda) | | - | Oral Medication | Diazepam 10mg OD orally for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Insomnia severity index greater than 7
Patients with anxiety disorders
|
|
| ExclusionCriteria |
| Details |
Patients with psychiatric illness like schizophrenia, psychosis, epilepsy, etc.
Patients with alcohol dependency or drug dependency.
Use of hypnotics by prescription, psychotherapy within the past 4 weeks.
Patients with other illness like asthma, malignancies, liver cirrhosis, chronic renal failure.
Patients recently on sleep pills
Patients with insomnia due to Chronic pain.
Patients suffering from drug induced insomnia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Polysomnography will be able to identify the type of nidranasha and the type of improvement in polysomnography content, may help in further evaluation and approach for nidra. |
0th day, 7th day and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLIACBLE |
NOT APPLIACBLE |
|
|
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)
|
01/02/2025 |
| 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="2"
Months="0"
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 is
a vital part of our well- being, throughout our life. Sleep is a biological
necessity, and insufficient sleep is detrimental to health. Its importance is
highlighted by the fact that it is included in tri upsthambh. According to Acharya
Charaka, sleep habits have a direct impact on various aspects of life,
including happiness and unhappiness, healthy physical growth and emaciation,
strength and weakness, virility and sterility, knowledge and ignorance, and
individual’s life and death. Inadequate quantity or quality of sleep adversely, affects quality of
life and increases risk for chronic disorders.[i]
The four
types of Murdha Tail that Acharya Vagbhatta has described are
Abhyanga, Parishek, Pichu, and Shirobasti. Each of these
types is progressively more beneficial than the one before it. Among them
is Shirodhara, also known as Shiroparishechan. Our ancient
textbooks contained references to Shirodhara for a number of ailments,
including Ardhavabhedaka, Suryavarta, Ardita, Pakshaghata, Hanugraha,
Akshishula, Nidranasha, Shirogata Vata, and Shirahkampa. It is one
of the popular forms of Panchakarma
therapy in use today.[ii]
Qualitative
analysis of sleep is not only as important as quantitative analysis, but it is
even more so. A sleep poor in quality is insufficient, even if it is adequate
in quantity. Polysomnography provides an important objective criteria to
analyse not only quantity but also quality of sleep, which is scarce in works
on this topic.
Sleep is not a constant phenomenon, it is a phasic process consisting of
NREM, REM stages. NREM is further classified in N1,N2,N3 sleep stage.
Nidranasha causes not only loss of sleep but there may be
disruption in the sleep pattern. Taildhara not only causes increase in
quantity of sleep, but also normalizes this sleep pattern.
Unfortunaley, not much refrence are seen on the effect of tail dhara
on these stages, and that is a must to understand and establish the effect of
tail dhara on sleep. Hence, due to absence of such studies on this topic,
qualitative analysis of effect of talidhara is need of the hour.
|