| CTRI Number |
CTRI/2025/01/078962 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Other (Specify) [Diet] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Non Pharmacological Therapy of Abhyangam and sunbathing, diversified diet, Pranayam and Yogasana as an adjuvant in the management of COPD |
|
Scientific Title of Study
|
Non Pharmacological Therapy (NPT consisting of Abhyangam and sunbathing, diversified diet, Pranayam and Yogasana) as an adjuvant in the management of COPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Sarwal |
| Designation |
Adjunct Professor |
| Affiliation |
ESIC Medical College |
| Address |
ESIC Medical College,
NIT 3,
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9013031950 |
| Fax |
|
| Email |
Sarwalr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMKSen |
| Designation |
Professor & HOD of department of Pulmonary Medicine |
| Affiliation |
ESIC Medical College Hospital Faridabad |
| Address |
Department of Pulmonary Medicine ESIC Medical College Hospital Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9968306997 |
| Fax |
|
| Email |
drmksen@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMona Jha |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College Hospital Faridabad |
| Address |
Department of Pulmonary Medicine ESIC Medical College Hospital Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9560328220 |
| Fax |
|
| Email |
monajha2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Faridabad. |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
NIT-3, Faridabad, Haryana. 121001 |
| Type of Sponsor |
Government medical college |
|
|
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 Rakesh Sarwal |
ESIC Medical College, Faridabad |
Integrative Health Clinic,
First Floor, In front of Blood Bank,
ESIC Medical College Hospital,
Faridabad
HARYANA
121001
India
Faridabad
HARYANA |
9013031950
sarwalr@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
abhyangam and sunbathing |
Select a suitable oil based on Patients body type or dosha.
Find a warm, quiet, and clean area where the patient can comfortably lie down.
Gently warm the oil by placing the container in a bowl of warm water for a few minutes.
Start by pouring a small amount of oil into your palm and rubbing your hands together to warm the oil.
Apply oil to the scalp and massage using circular motions with your fingertips.
Move to the face, using upward strokes on the cheeks and forehead, and circular motions around the eyes.
Apply more oil to your hands and massage the body, working in long strokes along the limbs and circular motions on the joints. Pay attention to areas of tension or discomfort. Focus on the joints: Spend extra time massaging the joints, such as the elbows, knees, and ankles, using circular motions.
Massage the abdomen in a clockwise direction, following the path of the digestive tract.
Finally, massage the feet, giving special attention to the soles and between the toes.
After the massage, relax for 10-15 minutes to allow the oil to penetrate the skin and nourish the tissues.
Post abhyanga, svedan kriya should be done as per the requirement. Repeat regularly:
Advise the Patient to aim to incorporate abhyanga into his/her routine on a regular basis, ideally before bathing or showering, to reap its full benefits for relaxation, nourishment, and overall well-being. |
| Intervention |
diversified diet |
Subjects will be provided a diversified diet once a day.
Food Ingredients, Amount (cooked).
Tomato soup: tomato, onion, garlic, ginger 200 ml
Sprouted mung salad Mung (30 g raw) 200 g Vegetables (Cucumber, onion, tomato , carrot, radish, beetroot) 250 g
Green Chutney
Mint and coriander leaves ,garlic ,green chili ,spinach , cumin seed 20 g
Multigrain flour chapatti
Wheat flour (50%) + jowar flour (20%) + bajra flour (20%) +ragi flour (10%) - 2 nos.
Beans or whole dal
Bengal gram / rajma/ white chana / lentil 120 g
Saag
Spinach + methi + bathua + sarson +garlic+green chili+besan 150 gm
Accompaniment
Lemon and green chilli
Fruit
Seasonal
Ghee and mustard oil
5 to 7 ml
Spices
5 gm |
| Intervention |
practice pranayama, yogasana |
Pranayama, an important part of yoga, has special importance to prevent and cure the side effects of COPD, any infection or disease on the respiratory system.
# First of all, we will practice Kapalbhati purification process.
We will do this exercise three times with 30 breath strokes.
# The second exercise is Surya BhediPranayam, which we will do for 3 to 5 minutes.
# The third exercise is Bhastrika Pranayama, which we will do three times with rapid breathing for 15 breath strokes. This completed our practice of Pranayam.
Basically, it will take about 12 minutes and after that the patient will be advised to increase the exercise on his own.
Yoga can help a person with chronic obstructive pulmonary disease (COPD) in many ways. It promotes deep breathing, reduces anxiety, maintains muscle strength, and increases flexibility.
If we treat such a patient through yoga, then first of all we will bring the patients mind to a positive state and make him aware of the benefits of yoga.
Yogasana will be practiced by dividing it into four categories.
Asanas to be done by lying straight on the back.
Asanas which are done by lying upside down on the stomach.
Asanas to be done sitting.
Asanas to be done while standing.
Also, to provide special benefits to the patient, we will practice the following asanas.
1. Wind-free pose
2. Matsyasana
3. Bridge pose
4. Monkey Pose
5. Snake Pose/Bhujangasana
6. Dhanurasana
7. Vajrasana
8. Mandukasana
9. Gomukhasana
10. Vakrasana
11. Camel Pose
12. Marjari Asana
13. Chakrasana (standing)
14. Trikonasana
15. Surya Namaskar (short form)
All the above yogasana exercises will be done with two repetitions of 15 seconds. The patient will be told to do these exercises in the morning and evening. Along with this, he will also be given detailed information about the method of the asana and the dos and donts related to it in the beginning.
1. To practice yoga asanas, they will be given training in the yoga department, for which yoga mats will be utilized as per the number of patients.
2. The yoga practitioner will be told about the appropriate dress for doing yoga.
3. Mainly, four repetitions of 15 seconds to 30 seconds can be done for any yoga exercise and repeating these exercises in the morning and evening will prove to be more beneficial. |
| Comparator Agent |
Standard of Care for COPD cases |
Standard protocol of care for COPD cases will be administered to controls. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of COPD.
2. Stage I, II and III COPD, clinically stable for at least 3 months.
3. Sufficient cognitive function to follow instructions for spirometry.
4. Able to walk without aid.
5. Willingness to undergo the prescribed modified lifestyle protocol of NPT
6. Provide informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion
1.Myocardial infarction within last 3 months
2.Asthma
3.Recent surgery of thorax, abdomen, head, eyes or ear.
4. Haemoptysis.
5.Severe hypertension (BP more than 200/120 mm Hg).
6.Recurrent angina within the previous six months.
7.Recent injury or neuromuscular conditions interfering with exercise tests.
8.Current Smokers.
9.Active Tuberculosis infection. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective Outcome Parameters:
1. The efficacy of the NPT regimen will be evaluated based on various objective measures, including vital signs such as blood pressure (BP), pulse rate (PR), respiratory rate (RR), and oxygen saturation (SpO2), as well as findings from chest examinations.
2. Pulmonary function tests, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio. We will assess lung functions using spirometry.
3. Laboratory investigations will monitor changes in complete blood count (CBC), liver function tests (LFT), kidney function tests (KFT), serum electrolyte levels, random blood sugar (RBS), high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), vitamin D levels, D-dimer, and lipid profile. In addition, the occurrence of respiratory infection will be evaluated to assess the impact of the intervention. |
12 weeks objective Outcome Parameters |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Outcome Parameters
1. Subjective outcomes will focus on the patients perception of their COPD symptoms and overall well-being.
2. Dyspnoea severity will be assessed using the Modified Medical Research Council (MMRC) Dyspnoea Scale. Health related quality of life will be measured using the St. Georges Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT). |
12 wks |
| 3. Mental health status will be evaluated using the WHO (Five) Well Being Index, while sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). These subjective measures will provide insights into the impact of the NPT regimen on symptom burden, functional status, mental health, and sleep disturbances experienced by COPD patients. |
12 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sarwalr@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 01-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality globally. Non-Pharmacological Therapies (NPT) can complement standard pharmacological treatments for COPD. Abhyangam (a traditional Indian oil massage) improves circulation, reduces stress, enhances lung function, and promotes relaxation. Sunbathing provides vitamin D, which is crucial for bone health and immune function. Diversified diet ensures the intake of essential nutrients, supports overall health, and can reduce inflammation. Pranayam (breathing exercises) may enhance lung capacity, improve oxygenation, and promote relaxation. Yogasana improves flexibility, strengthens respiratory muscles, reduces stress, and enhances overall physical fitness. Such interventions focus on improving overall health, enhancing lung function, and alleviating symptoms through natural and holistic approaches. When used in conjunction with, not as replacement for conventional medical treatments, NPT potentially holds promise for a comprehensive management of COPD. |