| CTRI Number |
CTRI/2024/06/068876 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of single point and oscillatory method of shirodhara in Primary insomnia(Anidra) using Tungadrumadi Taila. |
|
Scientific Title of Study
|
Randomized open labelled
comparative clinical study to
evaluate the efficacy of single point and oscillatory method of Shirodhara using Tungadrumadi Taila 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 Anupama G L |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-8, Department of Panchakarma-OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
8310699650 |
| Fax |
|
| Email |
anupamagl1256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Puttur |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-8, Department of Panchakarma-OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9538176059 |
| Fax |
|
| Email |
drganeshputtur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Puttur |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-8, Department of Panchakarma-OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9538176059 |
| Fax |
|
| Email |
drganeshputtur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore, Karnataka, India, Pin code - 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Anupama G L |
| Address |
Sri Sri College of Ayurvedic Science and Research, Bangalore, Karnataka, India, Pin code - 560082. |
| 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 Anupama G L |
Sri Sri College of Ayurvedic and Research Hospital. |
Room no-8, Department of Panchakarma-OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA |
8310699650
anupamagl1256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 | - | tailadhArA, तैलधारा | (Procedure Reference: Panchakarma illustrated by Shrinivas Acharya g, Procedure details: Procedure details: Poorvakarma - Sambhara Sangraha & Swastivachana. Pradhanakarma - Group 1- single point method - the medicated liquid - Tungadrumadi Taila will be made to flow on the single point that is on the center of forehead continuously and steadily. Duration - 45 min/day. Total course of treatment-7 days. Paschatkarma- patient will be asked to take rest for 15 min and then take head bath with warm water and follow Ushnopachara)
| | 2 | Comparator Arm | Procedure | - | tailadhArA, तैलधारा | (Procedure Reference: Panchakarma illustrated by Shrinivas Acharya g, Procedure details: Poorvakarma - Sambhara Sangraha & Swastivachana. Pradhanakarma - Group-2 - Oscillatory method - when the medicated liquid - Tungadrumadi Taila- starts flowing steadily onto the forehead of the subject, the Dhara pot will be oscillated constantly & steadily in to and fro motion across the forehead from one lateral to the other. Duration - 45 min/day, Total course of treatmen - 7 days. Paschatkarma- patient will be asked to take rest for 15 min and then take head bath with warm water and follow Ushnopachara.)
(1) Medicine Name: Tungadrumadi Taila, Reference: Sahasrayoga Taila Prakarana, Route: Topical, Dosage Form: Taila, Dose: 2000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects between the age group of 21 – 60 years, irrespective of their
gender, religion, occupation, and socioeconomic status.
2) Subjects with insomnia features as mentioned in DSM-5-TR Diagnostic
Criteria of Primary Insomnia.
3) Subjects fit for Shirodhara.
4) Subjects who are willing to give written consent for the treatment. |
|
| ExclusionCriteria |
| Details |
1) Subjects below 21 years and above 60 years of age.
2) Subjects with insomnia associated with Psychiatric disorders,
Uncontrolled hypertension, uncontrolled diabetes mellitus with polyuria
during the night and with HbA1c ≥ 8, with a history of Stroke,
Haemorrhagic disorders, Epilepsy, etc.
3) Subjects with insomnia due to alcohol or drug dependency.
4) Pregnant and lactating women.
5) Subjects unfit for Shirodhara. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Generation of evidence to show that either both methods would provide similar results or one of the two methods would be superior to the other - using Athens Insomnia scale.
|
0th day, 8th day, 15th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in-depth analysed data on the different aspects of Shirodhara, Anidra, & primary insomnia.
|
24 weeks
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="0"
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 Trayopastambha,1 i.e., three pillars of life; any disturbance in it hampers the quality of life. Sleep is the fundamental human need and a crucial component of both physical and mental health. It is vital for restoring energy consumed during the day and plays a key role in maintaining metabolic and endocrine functions, as well as improving cognitive functions like memory.2 According to Acharya Vagbhata, Nidra furnishes Sukha, provides Pushti, Bala, Vrishata, Jnana, and Jeevana to Purusha. On the contrary, Anidra causes Dukha, Karshya, Bala Hrasa, Kleebata, Ajnana, and Marana. 3 Thus, Anidra may hamper the equilibrium of the Tridoshas leading to severe derangement in Dhatus. In contemporary science, due to the close resemblance in the Lakshanas, Anidra can be correlated with primary insomnia. The American Academy of Sleep Medicine defines insomnia as unsatisfactory sleep that impacts daytime functioning.4 Insomnia disorder is highly prevalent in the general population, with estimates of 10% among adults, among them 2-6 % use medications to aid sleep.5 Another Indian study identified 15.4% prevalence of primary insomnia.6 A study among corporate employees in India showed a prevalence of insomnia in 13.8% of participants.7 Insomnia is associated with increased morbidity and mortality caused by cardiovascular diseases and psychiatric disorders and has other major public health and social consequences, such as accidents and absenteeism.8 In developing countries like India the incidence of primary insomnia is increasing even in people not suffering from comorbid chronic physical illness. The Modern medical science is still not having a definite treatment for insomnia. Present treatment includes cognitive behavioural therapy (CBT), use of antihistamines, sedative-hypnotics like benzodiazepines, use of anticonvulsants, antipsychotics, barbiturates and nonhypnotic benzodiazepines. Many of these medications involve a significant level of risk. Most sedative and hypnotic drugs produce a dose-dependent depression of central nervous system function. The use of benzodiazepines produces central nervous depression including drowsiness, impaired motor coordination, confusion, memory loss, blurred vision, hallucinations and paradoxical reactions. The ideal hypnotic drug should allow the patient to fall asleep quickly, should maintain sleep of sufficient quality and duration so that the patient awakes refreshed without a drug hangover.10 The contemporary system of medicine is lacking in fulfilling these criteria. Hence, it becomes imperative to search out treatment that is safe and effective, without any adverse effects or withdrawal phenomena, from natural systems of medicine. Among many modalities mentioned by Acharyas, Shirodhara is an effective treatment for psychiatric and sleep disorders. A study, published by Japanese researchers showed Shirodhara has anxiolytic and ASC-inducing effects, and it promotes a significant decrease in plasma levels of noradrenaline,11 which is one of the key factors in inducing andmaintaining sleep.In clinical practice, Shirodhara is usually practiced in the oscillatory method. Studies related to the single-point method of Shirodhara are needed, to note its efficacy over the oscillatory method. Hence, the study is planned to compare the efficacy of the single point method and oscillatory method of Shirodhara using Tungadrumadi Taila in the management of Anidra. |