| CTRI Number |
CTRI/2025/03/081874 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to Evaluate the Efficacy of Acupuncture in Sleeplessness |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ACUPUNCTURE IN INSOMNIA
WITH SPECIAL REFERENCE TO ANIDRA |
| 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 Vinod |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
9980805158 |
| Fax |
|
| Email |
vmakkalli@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakshith K R |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
974390965 |
| Fax |
|
| Email |
ramrakshi31@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vinod |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
9980805158 |
| Fax |
|
| Email |
vmakkalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore Karnataka
|
|
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Primary Sponsor
|
| Name |
Dr vinod |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 |
| Type of Sponsor |
Other [self] |
|
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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 Vinod |
Sri Sri College of Ayurvedic Science and Research |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore Karnataka
Bangalore KARNATAKA |
09980805158
vmakkalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri institutional ethical comitte |
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:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Acupuncture | (Procedure Reference: Daniel Johnson. insomnia.in: relevance of acupuncture in the 21 st century for the treatment of chronic ailments, 1 st ed. Mangalore: IAA publications; 2022, p. 84., Procedure details:
Materials required: Needles, Alcohol swabs, Cotton swabs, Treatment bed, Sharps disposal
container.
Procedure:
The subject will made to lie in supine position & instructed to uncover the area of the acupoints
for sterilization.Then, the eyes will be covered with bandage roll.Sterile, stain less-steel needles will be inserted quickly at the identified point. The needle will then remain in position for 25 minutes. subjects often endorse numbness or mild
radiculopathies that may radiate. After the procedure subjects will be advised to take rest for 15minutes.)
| | 2 | Comparator Arm | Procedure | - | Shiro Abyanga | (Procedure Reference: Charaka samitha, Procedure details: Purva Karma: The subject will be made to sit on a knee-high chair. The body of the subject
will be covered with a cloth below the neck, then the procedure will be carried out by standing
behind the subject; which is the ideal position to perform Shiroabyanga.
Pradhana Karma: The technique includes smearing the oil to the portions of the scalp above
the neck & placing specific strokes. The oil will be heated by placing on a water bath until it
became Sukhoshna i.e. near about to body temperature. Then the oil will be applied on to the
head of the subject & spread all over the head including the neck and ear pinna. In case of
short trimmed hair, to spread the oil on the scalp moving the palms from before backwards is
enough. If the subject has long-hair then the fingers will be poked between the hairs to smear
the oil to the scalp.
a) Gharshana Hasta (Massage from before backwards)
b) Mridvanguli Tadana (Picking strokes)
c) Dvihasta Tadana (Flat palm strokes)
d)Taranga Hasta (Rocking strokes)
e) Anguli Kridana Hasta (Finger strokes)
f) Mridu Mushti Tadana (Fist stroke)
g) Squeeze strokes
h) Ghatita Hasta
i) Karna Abhyanga
Rasnadi Churna will be used to cleanse the oil. Then the subject will be asked to rest on the
chair for about 15 minutes and then will be instructed to take head bath.) (1) Medicine Name: Tungadrumadi taila, Reference: Sahasra yoga, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject of age group between 21-60 years, irrespective of gender, religion, occupation, and socioeconomic status will be selected.
2.Subjects with classical signs and symptoms of Anidra and Primary Insomnia.
3.Subjects willing to give informed consent.
4.Subjects fit for Acupuncture and Shiroabyanga.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have underwent treatment for Insomnia in the past 2 weeks.
2.Subjects who have been diagnosed with the psychiatric disorder or a history of major neuropsychiatric disorder. (for example autism, learning disorder, mental retardation and so on)
3.Subjects who have infection or inflammation at the acupoints.
4.Subjects diagnosed with hemorrhagic disease or anticoagulant intake.
5.Pregnancy and lactating mothers.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in quality of sleep based on Brief Psychiatric Rating Scale and PSQI Score. |
Pre-Study Assessment - 0th Day
1st Assessment - 7th day
Follow up - 14th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of in depth analysed data on different aspect of disease and its treatment.
2.Generation of data on possible unexpected reaction.
|
Pre-Study Assessment – 0thday
1st Assessment – 7th day
2nd Assessment – 14th day
|
|
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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)
|
01/04/2025 |
| 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="1" Months="6" Days="0" |
|
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
|
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Brief Summary
|
Nidra is one among the three Upasthambas for the maintenance of the living organism. Nidra is a natural state of rest for the mind and body, involving partial or complete loss of consciousness with closed eyes. Anidra is a sleep disturbance linked to Insomnia, characterized by difficulty initiating, maintaining, or improving sleep, leading to daytime impairment. Approximately 10% of the adult population suffers from an Insomnia disorder and another 20% experiences occasional Insomnia symptoms. Women, older adults, and people with socioeconomic hardship are more vulnerable to Insomnia. Insomnia is often a chronic condition, with a 40% persistence rate over a 5 year period. Insomnia is a significant public health problem that should be addressed at the individual level with appropriate clinical care. Primary Insomnia is a sleep disturbance that cannot be attributed to medical, psychiatric, or environmental cause. On the other-hand secondary Insomnia caused by an underlying medical condition or a medication. Hypnotic medications like benzodiazepines and non-benzodiazepines are often used for treatment but carry risks, including an increased risk of Dementia. Shiroabyanga is a form of Bahirparimarjana Chikitsa and are also a part of Dinacharya, is told to be beneficial in inducing Nidra. Hence the same has been employed in the present study. Charaka Samhita mentioned that Shiroabyanga helps to promote Nidra, prevents headache, greying, hair fall and it also gives strength to skull, strengthens hair root. It also nourishes the sense organs, softens the skin and one gets good sleep after Shiroabyanga. Medical Acupuncture is a system which can influence three areas of healthcare – promotion of health and wellbeing, prevention of illness, treatment of various medical conditions. The World Health Organization (WHO) recognize the use of acupuncture in the treatment of wide range of medical problems including digestive disorders, respiratory disorders, neurological disorders, muscular disorders, urinary, menstrual and reproductive problems. Acupuncture mainly has six effects i.e, analgesic effect, sedation effect, homeostatic or regulatory effect, immune-enhancing action, psychological effect, which is calming and tranquilizing action apart from mere sedation. It also helps in motor recovery in patients who have become paralyse. Needling of certain specific Acupuncture points results sedation. Some people may even fall asleep during treatment, but wakeup refreshed, it has been shown that there is a decrease in delta and theta wave activity on the electro-encephalogram during Acupuncture treatment. These effects utilised in the Acupuncture treatment for Insomnia, Anxiety states, addictions, Epilepsy, mental disorders and behavioural problems. Hence this study is taken up to evaluate the effect of Acupuncture in Anidra w.s.r. to Primary Insomnia. |