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CTRI Number  CTRI/2024/06/068776 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 06/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study to find the effectiveness of Sanjeevi Thailam (External-oil bath) and Plain Amukkara chooranam (Internal) with Sanjeevi Thailam(External-oil bath)in the management of Thookaminmai(Insomnia). 
Scientific Title of Study   A Clinical Trial to evaluate the effectiveness of Sanjeevi Thailam (External-oil bath) and Plain Amukkara chooranam (Internal) with Sanjeevi Thailam(External-oil bath)in the management of Thookaminmai(Insomnia)among out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha. 
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 KAVYASRI V 
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu

Kancheepuram
TAMIL NADU
600047
India 
Phone  8072535167  
Fax    
Email  kavyasiddhadoc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR LAKSHMIKANTHAM T 
Designation  Associate Professor & Head of the Department (i/c) 
Affiliation  National Institute of Siddha 
Address  Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu

Kancheepuram
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR LAKSHMIKANTHAM T 
Designation  Associate Professor & Head of the Department (i/c) 
Affiliation  National Institute of Siddha 
Address  Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu

Kancheepuram
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram sanatorium,Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu 
Type of Sponsor  Research institution and hospital 
 
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 KAVYASRI V  Ayothidoss Pandithar Hospital  Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium Chennai Tamilnadu
Kancheepuram
TAMIL NADU 
8072535167

kavyasiddhadoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sanjeevi Thailam and Sanjeevi Thailam with Plain Amukkara Chooranam  70 ml of oil for external oil bath per week for 48 days and 70 ml of oil for external oil bath per week for 48 days with 2 gms of Plain Amukkara Chooranam for 48 days  
Comparator Agent  Sanjeevi Thailam and Sanjeevi Thailam with Plain Amukkara Chooranam  70 ml of oil for external oil bath per week for 48 days and 70 ml of oil for external oil bath per week for 48 days with 2 gms of Plain Amukkara Chooranam for 48 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Age between 18 - 80 years.
2.Sex: Male, Female
3.Students, Faculties, Workers in National Institute of Siddha.
4.Attenders of participants visiting OPD.
5.Pittsburgh Sleep Quality Index 15(Global PSQI) from 5 to 21 will be included. assessment, pittsburgh psqi.doc
6.Participants who are willing to sign the written Informed Consent Form.
 
 
ExclusionCriteria 
Details  1.Shift Workers, Drivers, Drug users.
2.K/C/O Participants with uncontrolled Hypertension.
3.K/C/O Diabetes
4.K/C/O Sinusitis
5.K/C/O Chronic renal failure
6.K/C/O Coronary artery disease
7.K/C/O Depression
8.Pregnancy and lactation
9.Malignancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the reduction in the scores by 25-50% of Insomnia participants between groups A and B (before and after treatment) using the Pittsburgh Sleep Quality Index.   Raw drug selection 15 days
Medicine preparation 15 days
Patient selection 1 month
Treatment plan 45 days
Data collection 1 month
Data analysis 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   26/06/2024 
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="0"
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  

BACKGROUND:

Siddha system is one of the ancient and codified medical systems of India. According to the Siddha system, diet and lifestyle play a major role in maintaining promotion of health and in the management of diseases. In the current world, life style modification like food habit, lack of exercise, stress factor causes many diseases. Insomnia is one among them. It may be correlated to Thookaminmai or Nithiraiinmai in siddha system of medicine.

            Insomnia a type of sleep disorder is one among the life style modification disorder which is a serious health problem among older adults due to its linkage with worsening general health, reduced quality of life, and morbidities, such as falls, institutionalization, and cognitive impairment. Age-related biological changes that result in less deep sleep, more fragmented sleep, and early morning wakeups are one theory of why older adults are more likely to experience insomnia.

             In fact, chronic illnesses are a significant risk for insomnia. It is estimated that the majority of people with insomnia (approximately 75%–90%) have an increased risk for comorbid medical disorders, such as conditions causing hypoxemia and dyspnea, gastro esophageal reflux disease, pain conditions, and neurodegenerative diseases. Importantly, a variety of primary sleep disorders as well as circadian rhythm disorders are frequently comorbid with and often lead to insomnia.

OBJECTIVE:

                   To compare the therapeutic effectiveness of Sanjeevi thailam (external-oil bath) and Plain Amukkara Chooranam (internal) with Sanjeevi thailam(external-oil bath) in the management of Thookaminmai (Insomnia) using Pittsburgh Sleep Quality Index.


METHODOLOGY:

STUDY DESIGN :       Interventional Study.

STUDY PLACE :      Out Patient Department,

Ayothidoss Pandithar Hospital,

                                         National Institute of Siddha,                   

                                         Chennai-47.


SAMPLE SIZE :      20 (Group A – 10, Group B – 10)

STUDY PERIOD :      48 DAYS 

JUSTIFICATION FOR CONDUCT OF THE STUDY:

Nowadays, there is an increasing prevalence of insomnia throughout the world. Though lifestyle intervention is the mainstay of treatment for insomnia, the need for medications of the same is rising.

In other system of medicines, the regular intake of medicines leads to drug dependency both physically and emotionally. The damage by taking sleeping pills so often may have continuous, even life-long consequences that involve addiction to sleeping pills and all the side effects that come along with it.

So, the drug “SANJEEVI THAILAM and PLAIN AMUKKARA CHOORANAM with SANJEEVI THAILAM” is chosen as a safer option in the management of insomnia. 


DATA ANALYSIS:

After enrolling the participant in the study, a separate file will be maintained for each and every participant. All the Clinical research Forms will be collected and safely stored for analysis. All clinical data entered in the Proforma will be analyzed. The data entry will be monitored in the presence of guides under the supervision of the Head of the department. All collected data will be entered using MS Access/excel software on the computer. All forms will be scrutinized by the Statistician for logical errors and incompleteness of data to avoid bias. The data will be statistically analyzed. No modification in the results will be permitted for unbiased reports.


OUTCOME:

            To compare the reduction in the scores by 25-50% of  Insomnia participants between groups A and B (before and after treatment) using the Pittsburgh Sleep Quality Index.


RESULTS AND DISCUSSION: The results will be statistically analysed and reported.


KEYWORDS:Thookaminmai,Insomnia.

 
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