| CTRI Number |
CTRI/2024/10/075517 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare efficacy of Kapalbhati and sukshama vyayam techniques, nadishodhana pranayama in the management of obesity |
|
Scientific Title of Study
|
Randomized comparative clinical trial to evaluate the effect of kapalbhati and sukshama vyayam techniques, nadishodhana pranayama in the management of sthaulya |
| 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 Rajendra Vinayak Patil |
| Designation |
Assistant professor |
| Affiliation |
Bhaisaheb Sawant ayurveda college and hospital,Sawantwadi.416510 |
| Address |
Department of Swasthavritta and Yoga Swasthyarakshan OPD no 07 Bhaisaheb Sawant ayurved college and hospital new khaskilwada Sawantwadi
Sindhudurg
MAHARASHTRA
416510
India |
| Phone |
9422565134 |
| Fax |
|
| Email |
dr.rvpatil@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Nakil |
| Designation |
H.O.D. and Professor |
| Affiliation |
L.R.P. Ayurvedic medical college,hospital,Post graduate institute and Research center,Islampur |
| Address |
1 St floor,Department of Swasthavritta and Yoga.L.R.P. Ayurvedic medical college,hospital,Post graduate institute and Research center,Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Vinayak Patil |
| Designation |
Assistant professor |
| Affiliation |
Bhaisaheb Sawant ayurved college and hospital Sawantwadi |
| Address |
Department of Swasthavritta and Yoga Swasthyarakshan OPD no 07 Bhaisaheb Sawant ayurved college and hospital New khaskilwada Sawantwadi
Sindhudurg
MAHARASHTRA
416510
India |
| Phone |
9422565134 |
| Fax |
|
| Email |
dr.rvpatil@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaisaheb Sawant ayurved college and hospital new khaskilwada Sawantwadi Dist Sindhudurg 416510 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Vinayak Patil |
| Address |
Bhaisaheb Sawant ayurved college and hospital new Khaskilwada Sawantwadi Dist Sindhudurg 416510 Maharashtra India |
| 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 Rajendra Patil |
Bhaisaheb Sawant Ayurved College and Hospital |
Deptartment of Swasthavritta and Yoga OPD Swasthyarakshan vibhag New Khaskilwada,Sawantwadi.416510
Sindhudurg
MAHARASHTRA |
9422565134
dr.rvpatil@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee R.J.V.S.Bhaisaheb Sawant Ayurveda Mahavidyalaya and hospital Sawantwadi,Dist.Sindhudurg 416510 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:In experimental trial subjects will be perform Yogic Sukshama vyayama techniques(standing and sitting position) 4 times in a single setting with 20 cycles of Nadishodhana pranayama at morning and evening on empty stomach for 3 months(90 days) while taking one or two minutes break between the cycles., Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Lifestyle-Kapalbhati kriya | In control trial subjects will be perform Kapalbhati kriya with maximum strokes (60 strokes per one minute) on empty stomach daily for 10 times in a single setting at morning and evening for 3 months(90 days) while taking one or two minutes break between the strokes cycles. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Age between 15 to 55 years.
Body mass index more than or equal to 25 kg/m2
Waist hip ratio more than 1.0 in male and 0.85 in female.
Patients having symptoms described in Ayurveda and modern science. |
|
| ExclusionCriteria |
| Details |
Age less than 15 and more than 55 years.
Any other systemic disorded and complications like Hypertenion Diabetes Mellitus coronary artery diseases Endocrinal disorder etc.
Patients having Deviated nasal septum Nasal polyps appendictitis acute abdomen hepatomegaly pharyngitis.
Having obesity as secondary disorder to any other major disorder to consider on the basis of history taking and and clinical examinations only without any laboratory investigations.
Ante Natal Cara and Post Natal Care patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sukshama vyayam techniques,Nadhishodhana pranayama and kapalbhati is effective in sthoulya, and also see the effect on body mass index,weight,abdomianal circumferences, mid arm circumferences. |
Two (02) follow up in ninety (90) days. One after 45 days of starting therapy and second after 90 days of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the effect of Sukshama vyayam techniques Nadishodhana pranayama & Kapalbhati kriya on lipid profile. |
Two(2) follow up in ninety(90) days.One after 45 days of starting therapy & second after 90 days of therapy. |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
25/10/2024 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of stduy is to see the effect of Kapalbhati and Sukshama Vyayam Techniques, Nadishodhana Pranayama in the management of Sthaulya or Overweight. The study will be conducted on 230 patients having sign and symptoms of Sthaulya and BMI more than 25 kg/m2 .This patients will be randomly divided into experimental and control group, containing 130 subjects in each. In experimental group patients were made to perform Kapalbhati-yogic shuddhikriya daily at morning whereas in comparison for control group Sukshama Vyayam Techniques or warm up exercises/loosening exercises. In experimental group maximum strokes of Kapalbhati i.e. 60 strokes per one minute to be performed on empty stomach daily for 10 times in a single setting for 3 months while taking one or two minute break between the stroke cycles. Perform these kapalbhati practices at every morning and evening with empty stomach with prior consent. In control group patients will be performed Sukshama Vyayam Techniques, Nadishodhana Pranayama at morning and evening for 90 days with prior consent. Statistical analysis will be done as follows. a)Paired ‘t’ test will be applied in each group to evaluate the significance of results for objective parameters. b)Wilcoxon rank signed test will be done to evaluate the effect of therapy on subjective parameters. c)Unpaired‘t’ test and Mann Whitney U test will be applied to compare the effect of treatment between these two groups. Conclusion will be drawn on the basis of proper statistical methods. |