| CTRI Number |
CTRI/2024/05/067357 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing effect of GIT cleaning and dry powder massage in obesity |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Shankhaprakshalana and Udvartana in management of sthoulya(Obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju |
| Designation |
Associate Professor |
| Affiliation |
Gangaputra Ayurvedic College and Hospital |
| Address |
Gangaputra ayurveda collage and Hospital,kandela, Jind
Dept. of Swasthavritta, Room No. 112
Institute of Ayurved Studies and Research Hospital, Kurukshetra (Shri Krishna AYUSH University, Krurukshetra)
Jind
HARYANA
126125
India |
| Phone |
08558852668 |
| Fax |
|
| Email |
drmanjuinsa12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Misar |
| Designation |
Professor, Dept. of Kayachikitsa |
| Affiliation |
MGACH&RC, Salod (H), Wardha |
| Address |
Dept. of Kayachikitsa, Room No. 30,
Mahatma Gandhi Ayurved Collage Hospital and Research Centre, Wardha, Maharastra, 442001
Nagpur
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
sadhanamisar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju |
| Designation |
Ph. D. Scholar |
| Affiliation |
Institute of Ayurved Studies and Research Hospital, Kurukshetra |
| Address |
Institute of Ayurved Studies and Research Hospital, Kurukshetra (Shri Krishna AYUSH University, Krurukshetra)
Gangaputra Ayurvedic College and Hospital, Jind, Hariyana
Kurukshetra
HARYANA
136118
India |
| Phone |
08558852668 |
| Fax |
|
| Email |
drmanjuinsa12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Institute of Ayurved Studies and Research Hospital, Kurukshetra (Shri Krishna AYUSH University, Krurukshetra) |
|
|
Primary Sponsor
|
| Name |
Dr Manju |
| Address |
Gangaputra Ayurvedic medical college, Kandela , Jind |
| 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 Manju |
Institute of Ayurved Studies and Research Hospital, Kurukshetra (Shri Krishna AYUSH University) |
OPD and IPD of Swasthavritta Department, Kurukshetra, Haryana
Kurukshetra
HARYANA |
08558852668
drmanjuinsa12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishana AYUSH University, Kurukshetra |
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:Shata Karma - Shankhaprakshalana , Pathya/Apathya:yes, Pathya:Puranashali ( Old variety of rice)
Raktashali(Red variety of rice)
Shasthikashali( Rice harvested in 60 days)
Yava( barley)
Kulatha( horse gram), ShrutaSheetajala (luke warm water)
Shunti siddha jala(Ginger water)
Madhu(Honey)
, Apathya:NavannaShali(New variety of rice)
Masha(Black gram), Tail(oil)
Sheet Jala(cold water)
| | 2 | Comparator Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Charaka Sutra Sthana 21, Procedure details: The major procedure used in Udvartana is the application of dry Triphalachurna to the body, followed by massage with some pressure in the opposite direction of the hair for 45 minutes for 14 days in first month & again 14 days in 2nd month.)
(1) Medicine Name: Triphala Churan, Reference: Sushruta Sutra sthana Chepter 38, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Male patients in the the age group of 20-40 years with BMI 25-40 kg/(m)2 having symptoms of Sthoulya like Atishudha(excessive hunger) Nidradhikya(excessive sleep) Alasya(lassitude) Swasakruchata(difficulty in breathing) |
|
| ExclusionCriteria |
| Details |
Obesity due to hormonal imbalance and secondary obesity
Female gender
Drug dependent cases(corticosteriods,tricyclic antidepressant,epilepsy medication, insulin)
Any other disorders in which patients cannot do his daily routine work or physical activity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Weight
2. Reduction in BMI
3. Measurement of Waist-hip ratio
4. Waist circumference
5. Reduction in Nidradhikya
6. Reduction in Alasya |
1. Objective parameters i.e. BMI, Weight in kg, Waist-Hip ratio and waist circumference are assessed before and after treatment
2. Subjective Parameters are i.e. Nidradhikya and Alasya are assessed on 0 day, 30th day and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Lipid profile before & after intervention
2. Change in FBS level before & after intervention |
0 & 60th day |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/05/2024 |
| 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 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 is single blind, randomized controlled trial comparing the clinical efficacy of Sankhaprakshalana once in a week for 60 days (total 8 sittings) and Udvartana daily for 14 days in first month and again 14 days in second month (120 patients in each group). The outcome will be measured on the basis of subjective, objective criteria and laboratory investigations before and after completion of treatment duration. |