| CTRI Number |
CTRI/2023/03/051177 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Madhutailika Basti (Enema) and Lekhana Basti (Enema) in Sthaulya (Obesity) |
|
Scientific Title of Study
|
An Open Labelled Comparative Clinical Trial Of Madhutailika Basti And Lekhana Basti In Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Arun Keram |
| Designation |
Assistant professor |
| Affiliation |
APMs Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune
Sion west
Mumbai
400022
Mumbai
MAHARASHTRA
411028
India |
| Phone |
8485022857 |
| Fax |
|
| Email |
drpriyankakeram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj P Tathed |
| Designation |
Assistant professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya, Sion Mumbai
Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9867715592 |
| Fax |
|
| Email |
drpankajtathed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Arun Keram |
| Designation |
Assistant professor |
| Affiliation |
APMs Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune
Sion west
Mumbai
400022
MAHARASHTRA
411028
India |
| Phone |
8485022857 |
| Fax |
|
| Email |
drpriyankakeram@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Arun Keram |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Arun Keram |
APMs Ayurved Mahavidyalaya & Seth R V Ayurved Hospital |
Panchakarma OPD Ground floor of APMs Ayurved Mahavidyalaya & Seth R V Ayurved Hospital Sion west
Mumbai
400022
Mumbai
MAHARASHTRA |
8485022857
drpriyankakeram@gmail.com |
| Dr Priyanka Arun Keram |
Sane Guruji Arogya Kendra |
OPD 6 Panchakarma OPD Ground floor of Sane Guruji Arogya Kendra Malwadi hadapsar Pune
411028
Pune
MAHARASHTRA |
8485022857
drpriyankakeram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC of APMs Ayurved Mahavidyalaya Sion |
Approved |
| IEC of MAMs SSAM Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: Sthaulya(Obesity), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sharangdhar Samhita, Procedure details: Total Duration of 16 days
Out of which 12 Madhutailika basti of 480 ml and 4 Matrabasti of Tilataila 60 ml)
(1) Medicine Name: Madhutailika Basti, Reference: Sharangdhar Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 12 Days(2) Medicine Name: Tilataila, Reference: NA, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 4 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sharangdhar Samhita, Procedure details: Total Duration of 16 days Out of which 12 Lekhana basti of 480 ml and 4 Matrabasti of Tilataila 60 ml))
(1) Medicine Name: Lekhana Basti, Reference: Sharangdhar Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 12 Days(2) Medicine Name: Tilataila, Reference: NA, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 4 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Sthaulya
BMI between 25-40
Basti arha patients
|
|
| ExclusionCriteria |
| Details |
Hypothyroidism and PCOS
Patients on steroids, diuretics
Basti anarha
Pregnancy and lactation
Known cases of any other systemic disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Madhutailika Basti and Lekhana Basti in Sthaulya in terms of the effect on Karada scan values |
30 DAYS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/04/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sthaulya is according to Ayurveda a disease related to Agnivikruti and digestion. Excess accumulation of medodhatu leads to Sthaulya. Basti is one of indicated treatment in Sthaulya. There are various formulations of Basti mentioned in Various Samhitas. Among them Madhutailika Basti and Lekhana Basti are selected for study. To compare the effect of Madhutailika Basti and Lekhana Basti in Sthaulya in terms of the effect on Karada scan values. Is there any difference in the effects of Madhutailika Basti and Lekhana Basti in Sthaulya? There is significant difference in the effects of Madhutailika Basti and Lekhana Basti in Sthaulya. |