| CTRI Number |
CTRI/2025/03/081610 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of Basti i.e. enema with Ayurvedic medicines in Obese patients and patients with abnormal cholesterol to reduce level weight and cholesterol |
|
Scientific Title of Study
|
A Clinical study of Lekhaniya Gana Basti in Sthaulya with Special Reference to Dyslipidaemia. |
| 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 Shriram Shivajirao Ragad |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Jalgaon |
| Address |
Department Of Panchakarma Government Ayurvedic College Jalgaon 26 2 Shri Gulabrao Deokar College Campus 56 1 Shirsoli Road
Jalgaon
MAHARASHTRA
425002
India |
| Phone |
7387468519 |
| Fax |
|
| Email |
shriramragad1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Ekanath Chavan |
| Designation |
Head of Department & Professor |
| Affiliation |
Bharati Vidyapeeth Campus College Of Ayurveda |
| Address |
Department Of Panchakarma Bharati Vidyapeeth Campus College Of Ayurveda Dhankawadi Campus Katraj Satara Road Pune
Department Of Panchakarma Bharati Vidyapeeth Campus College Of Ayurveda Dhankawadi Campus Katraj Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Ekanath Chavan |
| Designation |
Head of Department & Professor |
| Affiliation |
Bharati Vidyapeeth Campus College Of Ayurveda |
| Address |
Department Of Panchakarma Bharati Vidyapeeth Campus College Of Ayurveda Dhankawadi Campus Katraj Satara Road Pune
Department Of Panchakarma Bharati Vidyapeeth Campus College Of Ayurveda Dhankawadi Campus Katraj Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College, 56/1, Shri Gulabrao deokar engineering college campus, Shirsoli road, Jalgaon, Maharashtra, India. Pin 425002. |
|
|
Primary Sponsor
|
| Name |
Dr Shriram Shivajirao Ragad |
| Address |
Department of Panchkarma
Governemnt Ayurveda College
56/1 shri gulabrao Deokar college campus 56 1
shirsoli road
Jalgaon Maharashtra India 425002 |
| 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 Shriram Shivajirao Ragad |
Government Ayurveda College |
Department of Panchkarma
56/1 Shri Gulabrao Deokar College campus
Shirsoli Road 425002
Jalgaon
MAHARASHTRA |
7387468519
shriramragad1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharti Vidyapeeth (Deemed to be University) College of Ayurved Ethics Commitee |
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 | Intervention Arm | Procedure | - | Lekhaniy gan Kaalbasti | (Procedure Reference: Ashtang Hruday , Procedure details: Kalbasti for 15 days (Alternate) Anuvasan Basti(lekhaniy gan siddha tail)100ml Niruh Basti(Lekhaniy gan siddha kashyay)640ml))
| | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Diet Plan and exercise Kulath Mudga Yush Yava Leafy vegetables Beans Skimmed milk Yogasan, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Medoroga according to Charak Samhita Sutrasthan 21 4 9 Patients between the ages of 20 to 60 years old with symptoms of Sthaulya or dyslipidemia will be selected
Patients for diagnosis of Sthaulya will be undertaken as per WHO height weight chart BMI and raised lipid profile
Gender Both
|
|
| ExclusionCriteria |
| Details |
Patient with severe hypertension
Patient with evidence of renal and cardiac involvement
Patient with diabetes other endocrinal disorder and with long term steroid treatment
Patient having anorectal disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in sign and symptom of Sthaulya weight BMI Waist hip ratio Anthropometry skin fold thickness mid arm circumference abdominal girth thigh circumference Investigation Lipid profile |
0 15 30 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review thoroughly about Basti Karma as per Ayurvedic & to study etiopathogenesis & symptoms of Sthaulya (dyslipdemia) as per Ayurvedic & Modern Medicine respectively.
2. To Study the effect of Lekhaniya Gana Basti on lipid profile and to study the reduction in classical symptoms of Medoroga according to (Cha. Su 21/4,9) and Anthropometric parameter and Biochemical investigation like lipid profile.
|
3 Year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
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)
|
Lekhan Basti mentioned by Acharya Sushruta (Su. Chi. 37/8). But in this Basti designed4 using Lekhaniya Mahakashay mentioned in (Ch. Su. 4/8). But we made certain modifications in decoction which is replaced by Lekhaniya Mahakashay (compendium of 10 herbs which does emaciation) and thus instead of Lekahna Basti we tried to formulate Lekhaniya Gana Basti. In this Lekhaniya Gana Basti5 the Basti by using Lekhaniya Mahakashya as decoction part and using others ingredients which are conventionally used in Basti like rock salt, Cow’s urine, Kalka and honey. So, to validate this concept, present clinical work has been taken to evaluate the efficacy of Lekhaniya Gana Basti in Sthaulya. |