| CTRI Number |
CTRI/2024/06/069602 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effect of head massage done in traditional and Tiruka method with ksheerabala taila in non-organic insomnia |
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Scientific Title of Study
|
A comparative clinical study on shiro abhyanga done in conventional and Tiruka method with ksheerabala taila in non-organic 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 Devu S Vijayan |
| Designation |
P G Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9400615128 |
| Fax |
|
| Email |
devusvijayan95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devu S Vijayan |
| Designation |
P G Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9400615128 |
| Fax |
|
| Email |
devusvijayan95@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ambili Krishna |
| Designation |
Assistant Professor, Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala
Thiruvananthapuram KERALA 695001 India |
| Phone |
9847827220 |
| Fax |
|
| Email |
dr.ambilikrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and hospital, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Devu S Vijayan |
| Address |
PG Scholar, Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram 695001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devu S Vijayan |
Government Ayurveda College Panchakarma Hospital |
Department of Panchakarma, OP NO:1, Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram 695012 Thiruvananthapuram KERALA |
9400615128
devusvijayan95@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Government Ayurveda College Thiruvananthapuram, Kerala, India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 | Procedure | - | Siro~aBya~ggaH, शिरोरऽà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga hridaya sutrasthana 22/23-24, Procedure details: Luke warm oil is massaged on the scalp & keep it for 45 mins) (1) Medicine Name: Ksheerabala taila, Reference: Ashtanga hridaya chikitsa sthana 22/45-46, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽà¤à¥à¤¯à¤‚ग | (Procedure Reference: Raghavendra Swamiji ed.Anga Mardana by Tiruka;rpt edn. Malladi Halli: Sarvodaya Mudranalaya,;1983; 2nd chapter.p.52, Procedure details: Shiro abhyanga is done following 9 strokes with each form of stroke is continued for about 5 minutes, & thus the whole process of head massage takes about 45 minutes. The 9 strokes are as follows
• Smearing of oil
1. Gharshana hasta
2. Mridvanguli tadana
3. Dwi hasta tadana
4. Taranga hasta
5. Anguli kreedana hasta
6. Mridu mushti tadana
7. Squeeze strokes
8. Ghatita hasta
9. Ear massage) (1) Medicine Name: Ksheerabala taila, Reference: Ashtanga hridaya chikitsa sthana 22/45-46, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants fulfilling the diagnostic criteria.(which is:(a)The complaint is either of difficulty falling asleep or maintaining sleep, or of poor quality of sleep.
(b)The sleep disturbance has occurred at least three times per week for at least 1 month.
(c)There is preoccupation with the sleeplessness and excessive concern over its consequences at night and during the day.
(d)The unsatisfactory quantity and/or quality of sleep either causes marked distress or interferes with social and occupational functioning)
2.Between the age group of 20 to 60 years.
3.Participants willing to give informed consent.
4.Those who are fit for the application of Ksheerabala taila on scalp (Prior application of Ksheerabala taila over scalp for 3 days to rule out any adverse results)
|
|
| ExclusionCriteria |
| Details |
1.Active infections on scalp.
2.Allergic rhinitis and fever.
3.Non-organic insomnia due to substance abuse.
4.Taking any medication that could cause sedation.
5.Psychiatric and epileptic patients with and without medication
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in quality of sleep analyzed by Insomnia severity index, Visual Analogue Scale, Pittsburgh sleep quality index scale and Event evaluation scale |
0th day, 8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
09/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Non organic insomnia is a condition where there is difficulty in the initiation and maintenance of sleep, atleast 3 times in a week for minimum 1 month period, which results in a marked distress in social and occupational functioning, with an absence of any causative organic factor. In ayurveda it can be correlated as nidranasha, anidra, etc. It is an adaaraneeya vega and for the management of disease due to suppression of the urge of sleep, one should resort to sound sleep and massage. Nidranasha is a vataja nanatmaja vikara, mainly caused by vata dosha, in which Murdhni taila is mentioned as one of its treatment. Murdhini taila consist of four different procedures such as abhyanga, seka, pichu and vasti. As per the Textbook of angamarda by Tiruka, the author has described about 26 steps of massage out of which 6 steps are exclusively meant for shiro abhyanga. Later these are incorporated by recent author Dr Srinivasa Acharya and is summarized as 9 steps. In conventional method these step wise protocol is not followed. In Charaka Samhita it is mentioned that Shiro abhyanga helps to prevents headache, gives strength to skull, strengthens hair root, nourishes sense organs, softens skin, provides lustre to face and one gets good sleep. Since there are 2 methods available for shiro abhyanga a study is planned to analyze which method is more effective. 30 participants satisfying the inclusion criteria will be selected from the OPD of Govt. Ayurveda Panchakarma Hospital, Poojappura and will be divided into different strata according to severity of insomnia and will be randomly allocated to the two groups (fifteen in each group). In group A we are doing the procedure in conventional method and in group B Tiruka method, till attaining vyadhi samana or for a maximum of 7 days. Assessments will be done before treatment and after treatment using Insomnia severity index, Visual Analogue Scale and Pittsburgh Sleep Quality Index. Data obtained will be statistically analyzed using appropriate tests based on whether it follows a normal distribution curve or not and will be presented in the form of a dissertation |