| 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
|
|
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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 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 |
|
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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, |
|
|
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
|
|
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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 |
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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. |