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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  
 
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] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.)
2Comparator ArmProcedure-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
 
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.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
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
 
 
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
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.
 
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