| CTRI Number |
CTRI/2025/07/090349 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Efficacy of Kothanda Adangal (Varma Therapy) in Stress Management: An Open-Label Clinical Trial |
|
Scientific Title of Study
|
EVALUATING THE THERAPEUTIC EFFECTS OF KOTHANDA
ADANGAL (VARMA THERAPY) IN MANAGEMENT OF STRESS –
AN OPEN CLINICAL TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mangaleshwari |
| Designation |
Medical officer |
| Affiliation |
National Institute of Siddha |
| Address |
Opd no 20, Department of Noi Naadal, National Institute of Siddha, Tambaram sanatorium, Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
7904071635 |
| Fax |
|
| Email |
mangaleshwarib@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. G.J. Christian |
| Designation |
HOD (Noi Naadal) |
| Affiliation |
National Institute of Siddha |
| Address |
Opd no 20, Department of Noi Naadal, National Institute of Siddha, Tambaram sanatorium, Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
|
| Email |
gj.christian.nis@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Mangaleshwari |
| Designation |
Medical officer |
| Affiliation |
National Institute of Siddha |
| Address |
Opd no 20, Department of Noi Naadal, National Institute of Siddha, Tambaram sanatorium, Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
7904071635 |
| Fax |
|
| Email |
mangaleshwarib@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Chennai - Trichy Hwy, near Government Hospital, Tambaram Sanatoruim, Chennai, Tamil Nadu, India - 600047 |
|
|
Primary Sponsor
|
| Name |
Mangaleshwari |
| Address |
Opd no 20, Department of Noi Naadal, National Institute of Siddha, Tambaram sanatorium, Chennai-47 |
| 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 B Mangaleshwari |
National Institute of Siddha |
ROOM NO 20, DEPARTMENT OF NOI NAADAL,National Institute of Siddha Ayothidoss Pandithar Hospital Tambaram Sanatorium Chennai
Chennai
TAMIL NADU |
07904071635
mangaleshwarib@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Varma Therapy |
This study involves a Varmam therapy protocol using Kothanda Adangal to treat patients with stress-related symptoms. Before treatment, patients will provide informed consent and satisfy natural urges, and their vital signs will be recorded. The treatment involves Varmam application in sitting and lying positions using bare hands, with hands sterilized before and after treatment. The therapy will be conducted for 15-20 minutes, once daily, for 7 weeks, with a total of 14 sittings. After treatment, patients will be observed for 10 minutes. Certain precautions will be taken, such as avoiding treatment after meals or sleep, heavy lifting, and strenuous activities. The study will include patients aged 20-60 years with symptoms like headaches, tense muscles, and anxiety, while excluding those with severe mental health conditions, chronic medical conditions, and pregnancy. |
| Intervention |
Varmam therapy |
VARMAM THERAPY :(15-20 minutes, once daily, for 7 weeks, with a total of 14 sittings)
Kothanda adangal
Thilartha Varmam
Puruva Nadu Varmam
Natchathira Varmam
Chevi Kuthi Varmam
Alavadi Varmam |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are having the symptoms of Headaches,Tense muscles, sore neck and back,Fatigue, Anxiety, worry, phobias, Insomnia, Irritability, Bouts of anger, Boredom, Depression , Binge eating, Constipation and Restlessness
|
|
| ExclusionCriteria |
| Details |
patient who will meet any of the following criteria will be excluded from participation in this study:
Severe mental health conditions: Patients with severe mental health conditions, such as psychosis, bipolar disorder, or suicidal ideation
Chronic medical conditions: Patients with chronic medical conditions, such as diabetes, hypertension, or cardiovascular disease, that may interfere with the study
Pregnancy or breastfeeding
Current therapy: Patients who are currently receiving therapy or treatment for stress or anxiety
Substance abuse: Patients with a history of substance abuse or addiction
Contraindications to Kothanda Adangal: Patients with contraindications to Kothanda Adangal, such as bleeding disorders or pacemakers
Inability to provide informed consent
Coronary artery disease
Tuberculosis
Any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| |
1. Baseline (before treatment)
2. Post-treatment (after 7 weeks of treatment)
3. Follow-up (2 months after treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index (PSQI): The PSQI is a 19-item self-report questionnaire that assesses sleep quality & disturbances over a 1-month time interval.
|
Baseline (before treatment) Post-treatment (after 7 weeks of treatment)
Follow-up (2 months after treatment) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study evaluates the efficacy of Kothanda Adangal (Varma Therapy) in reducing stress levels and improving sleep quality in patients with chronic stress. The primary objective is to assess the effectiveness of Kothanda Adangal in reducing stress levels, as measured by the Perceived Stress Scale (PSS), while the secondary objective is to evaluate its impact on sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI). The study involves 40 patients with chronic stress who will undergo Kothanda Adangal therapy, preceded by purgation with Agasthiyar Kuzhambu. Patients will be assessed at baseline, post-treatment (7 weeks), and follow-up (2 months). The study aims to provide insights into the effectiveness of Kothanda Adangal in managing chronic stress and improving sleep quality. |