| CTRI Number |
CTRI/2022/10/046668 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Kapalbhati and Raktashali Manda in the management of Obesity(Overweight person) |
|
Scientific Title of Study
|
Randomized Comparative Clinical Trial to Study The Effect Of Kapalbhati With Raktashali Manda and Without Raktashali Manda In The Management Of Sthaulya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apurva shankarrao Hole |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved mahavidyalaya |
| Address |
OPD NO- 12 Department of Swasthavritta and Yoga Vidarbha Ayurved Mahavidyalaya Chhatri talao Road Farshi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9518353726 |
| Fax |
|
| Email |
apurvahole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay K Chopkar |
| Designation |
Guide and HOD Department of Swasthvritta and Yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
Vidarbha Ayurved Mahavidyalaya Chhatri talao Road Near Farshi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay K Chopkar |
| Designation |
Guide and HOD Department of Swasthvritta and Yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
Vidarbha Ayurved Mahavidyalaya Chhatri talao Road Near Farshi Stop Amravati
Amravati
MAHARASHTRA
444601
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO-12 Dept of Swasthavritta and Yoga Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Chhatri Talao Road Near Farshi Stop Amravati |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Apurva Shankarrao Hole |
Vidarbha Ayurved Mahavidyalaya and Hospital Amravati |
OPD No 12 Department of Swasthvritta and Yoga Vidarbha Ayurved mahavidyalaya Hospital Chhatri talao road near Farshi Stop Amravati
Amravati
MAHARASHTRA |
9518353726
apurvahole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S H V P M Vidarbha Ayurved Mahavidyalaya Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | | (Procedure Reference: Hathayogapradipika, Procedure details: Kapalbhati involves abdominal muscles contractions with forceful exhalation and natural inhalation. One can begin with one round of 15 strokes.This procedure was practiced for 15 mins daily.)
| | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: Bhaishajyaratnavali and Hathayogpradipika, Procedure details: Raktashali Manda-This kalpana is prepared by using rice and water in 1:14 proportion. Dose-2pal(80ml)/day.
Kapalbhati-Kapalbhati involves abdominal muscles contractions with forceful exhalation and natural inhalation. One can begin with one round of 15 strokes.This procedure was practiced for 15 mins daily.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient having classical sign and symptoms of sthaulya
2 patient with BMI greater than or equal to 25kg/m
3 Patient of Waist Hip ratio greater than or equal to 0.90 in male and greater than or equal to 0.85 in female |
|
| ExclusionCriteria |
| Details |
1 Any other systematic disorders and complications like HTN DM Endocrine Disorders etc
2 Patients having Nasal Polyps DNS Appendicitis Pharyngitis Hepatomegaly etc
3 ANC PNC |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete Remission from Sthaulya 75-100%
Marked Improvement in Sthaulya 50-75%
Moderate Improvement in Sthaulya 25-50%
Mild Improvement in Sthaulya 25%,
Unchanged 0% |
0th day
7th day
15th day
30th day
45th day
60th day
90th day
105th day
120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission in symptoms of Anaemia
Remission in symptoms of sthaulya |
15th day
65th day
90th day
120th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/10/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Radomized Comparative Clinical trial will be conducted to study the effect of Kapalbhati with Raktashali Manda on Sthaulya. trial will be conducted in our institute. Total 100 patients with inclusive criteria having classical sign and symptoms of sthaulya will be selected and will be divided in two groups. One group will be advised Kapalbhati with Raktashali Manda and other group will be advised only Kapalbhati and result will be compared .Primary outcome will be about Evaluation of sthaulya and the Secondary Outcome will be about assesment criteria of effect of therapy and result will be noted |