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CTRI Number  CTRI/2022/05/042438 [Registered on: 10/05/2022] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Lekhan Basti (enema therapy)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study to assess the effectiveness of Lekhan Basti(enema therapy) in Yoga Basti Schedule and Chaturbhadra Kalpa Basti Schedule in sthoulya(obesity) 
Scientific Title of Study   A comperative clinical study to evaluate the efficacy of lekhan basti in yoga basti krama and chaturbhadra kalpa basti krama in the management of sthoulya w.s.r to obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjaliben Ramanlal Gayakwad 
Designation  PG Scholar 
Affiliation  Parul Ayurved Hospital 
Address  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, limda, Vadodara, Gujarat Pin no- 391760

Vadodara
GUJARAT
391760
India 
Phone  7990962473  
Fax  02668-260201  
Email  anjaligayakwad37@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSangeeta H Toshikhane 
Designation  Professor and H.O.D 
Affiliation  Parul Institute Of Ayurved 
Address  303 room no- Department of Panchakarma, Parul Institute Of Ayurved,Parul University, limda, Vadodara, Gujarat Pin no- 391760

Vadodara
GUJARAT
391760
India 
Phone  9964596479  
Fax  02668-260201  
Email  sangeeta.toshikhane26791@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  DrSangeeta H Toshikhane 
Designation  Professor and H.O.D 
Affiliation  Parul Institute Of Ayurved 
Address  303 room no- Department of Panchakarma, Parul Institute Of Ayurved,Parul University, limda, Vadodara, Gujarat Pin no- 391760

Vadodara
GUJARAT
391760
India 
Phone  9964596479  
Fax  02668-260201  
Email  sangeeta.toshikhane26791@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, limda, Vadodara, Gujarat Pin no- 391760 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, limda, Vadodara, Gujarat Pin no- 391760 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjaliben Ramanlal Gayakwad  Parul Ayurved Hospital  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital,Parul University, limda, Vadodara, Gujarat Pin no- 391760
Vadodara
GUJARAT 
7990962473
02668-260201
anjaligayakwad37@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Yoga Basti: 8 Basti [CH.Si.1/48] , Procedure details: Yoga Basti Vidhi Purvakarma: N.B - selection of the patient, counselling of the patient, Basti preparation, Abhyanga with Murcchita Tila taila at kati, kushi, ubhaypada followed by Nadi Swedan. A.B - selection of the patient, counselling the patient, Abhyanga with Murcchit Tila taila at kati, kushi, ubhaypada followed by Nadi Swedan. Pradhana karma: N.B - Basti administration at – Nati - khsudharta state (in the morning) A.B - Basti administration at – Immediately after taking )
(1) Medicine Name: Lekhan Basti, Reference: Sushruta Chikitsa Sthana 38 chapter, Route: Rectal, Dosage Form: Not Applicable, Dose: 550(ml), Frequency: od, Duration: 8 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Chaturbhadra Kalpa Basti Krama: 12 Basti [Kashyapa Khila Sthan 8-23], Procedure details: Chaturbhadra Kalpa Basti Vidhi Purvakarma: N.B - selection of the patient, counselling of the patient, Basti preparation, Abhyanga with Murcchita Tila taila at kati, kushi, ubhaypada followed by Nadi Swedan. A.B - selection of the patient, counselling the patient, Abhyanga with Murcchit Tila taila at kati, kushi, ubhaypada followed by Nadi Swedan. Pradhana karma: N.B - Basti administration at – Nati - khsudharta state (in the morning) A.B - Basti administration at – Immediately after taking)
(1) Medicine Name: Lekhan Basti, Reference: Sushruta Chikitsa Sthana 38 chapter, Route: Rectal, Dosage Form: Not Applicable, Dose: 550(ml), Frequency: od, Duration: 12 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subject having signs and symptoms of Sthoulya explained in Ayurveda Text.
2.Age between 18 years to 60 years irrespective of gender, caste, religion.
3.Subjects having BMI between 25-40.
4.Subjects who are fit for Basti Karma.
5.Subjects who are ready to give written informed consent
 
 
ExclusionCriteria 
Details  1.Age less than 18 years and greater than 60 years.
2.Sthoulya associated with other known diseases like Diabetes Mellitus, Hypertension, hypothyroidism, cardiovascular diseases, hemiplegia and from other such disease in which the subjects cannot do his routine physical activities will be excluded.
3.Sthoulya with Pregnancy and with other significant associated illness, and ongoing menstruation, subjects who will Having cortico-steroids, Oral contraceptive pills will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Helps in Reducing Weight and increase in quality of life in obesity patient  Group A-8 Days of intervention
Group B-12 Days of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in quality of life and reduced the risk of lifestyle disorders in obesity patient  for 15 to 30 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/05/2022 
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="1"
Months="6"
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  

In the recent years, India is under siege of Junk food, alcohol and sedentary life style are leading us to silent self-destruction, making one in every five Indian men and women either obese or overweight. Its prevalence has increased threefold according to WHO estimation in 2016, more than 1.9 billion adults are overweight, of these over 650 million were obese.

In Panchakarma, Sodhana karma is mainly done through Vamana and Virechana , which is strictly contraindicated in Sukumara. And Snehapana, along with Purva , Pradhana, Paschat karma and Samsarjana krama, it is too long which is almost same as Basti schedule or more. Among them Basti stands unique because it expels the vitiated doshas rapidly and easily from body.

 There are different patterns explained like Yoga Basti, Kala Basti, Karma Basti and different research works have been carried out on these three patterns but regarding Chaturbhadra Kalpa Basti krama which is Niratyaya and can be given in Sukumara which is mentioned in Kashyap Samhita; there is less research work has been done. Therefore, it’s the main reason to choose this pattern of Basti as it is mainly indictaed in Sukumara as Niratyaya, which is easy as compared to Vamana and Virechana Karma and this Basti pattern having no complications than Vamana and Virechana karma, but while these two Sodhana karmas has more precautions that are needed to be followed.

 Kasyapa Samhita is mainly used for Bala rogas, and it is not being referred in case of adults. In Kasyapa Samhita, the different Yogas and treatment are mainly for Paediatric age groups, who are generally Sukumara.Hence, here is an attempt to prove the efficacy of Chaturbhadra kalpa Basti pattern in adults also. If it is effective in adults, then further research studies and clinical practices can be done referring Kasyapa Samhita, which is omitted in today’s current research work and clinical practice in adults.

According to Sharangadhara and Sushīruta Samhita it is mentioned that first Utkleshana then Doshahara and in last Samshamaneeya Basti should be given, in this way we can understand Chaturbhadra Kalpa Basti Krama, as first 4 Anuvasana may act as Utkleshana Basti next 4 Niruha Basti may act as Doshahara Basti and last 4 Anuvasana Basti may act as Samshamaneeya Basti.

STUDY DESIGN

AIM: A comparison the efficacy of Lekhan Basti in Yoga Basti krama and Chaturbhadra kalpa Basti krama in the management of Sthoulya.

OBJECTIVES

  1. To Study the Effect of Shodhana Karma in Lekhan Basti by Yoga Basti Krama in The Management of Sthoulya.
  2. To Study the Effect of Shodhana Karma in Lekhan Basti by Chatur Bhadra Kalpa Basti Krama in The Management of Sthoulya.
  3. To Compare the Efficacy of Lekhan Basti In Between Chatur Bhadra Kalpa Basti Krama and Yoga Basti Krama.
  4. To prove significant role of Basti Krama for Shodhana Karma in the management of Sthoulya.

RESEARCH QUESTION  - Whether the Shodhana karma by Lekhan Basti in Chaturabhadra Kalpa Basti Krama and Yoga Basti Krama is effective in the management of Sthoulya?

 HYPOTHESIS:

Null Hypothesis (H0):Neither the Yoga Basti Krama nor the Chaturabhadra Kalpa Basti Krama for Lekhan Basti is effective in the management of Sthoulya..

Alternate Hypothesis

(H1): Chaturabhadra Kalpa Basti Krama is effective in the management of Sthoulya.

(H2): Yoga Basti Krama is effective in the management of Sthoulya.

 (H3): Both Chaturabhadra Kalpa Basti Krama and Yoga Basti Krama is effective in the management of Sthoulya.

 

MATERIALS AND METHODS

(A)Sources of data

Literature Source:All the classical, modern literatures, journals, websites about the disease and drugs will be reviewed and documented for the planned study.

Pharmaceutical source: Moorchhita Tila Taila for Anuvasan Basti will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurved.Niruha Basti will be prepared at Parul Ayurveda Hospital under proper SOPs.For Abhyanga Karma a Poorva Karma of Basti, Moorchhita Tila Taila will be used and for Swedana Karma Dashmoola Kashaya Nadi Swedana will be used.

METHOD OF COLLECTION OF DATA

Study Design: – Randomized Comparative Clinical Study with Pre and Post assessment.

Treatment Groups:

 

GROUP A

GROUP B

Type of Group

Control group

Study group

Basti krama

Yoga basti krama

Chaturbhadra kalpa basti krama

Sample size

20

20

Duration of treatment: 

8 days

12 days

 





Study Duration: 18 months

SELECTION CRITERIA: 40 Patient will be selected from OPD and IPD of Parul Ayurveda Hospital, Parul University,and various Health Checkup Camps.

 DIAGNOSTIC CRITERIA: The patients will be examined before Basti karma and after completing basti schedule. Changes in patient’s condition will be noted & following points will be taken in consideration for the assessment of the results.          

INCLUSION CRITERIA

1.     Subject having signs and symptoms of Sthoulya explained in Ayurveda Text.

2.     Age between 18 years to 60 years irrespective of gender, caste, religion.

3.     Subjects having BMI between 25-40.

4.     Subjects who are fit for Basti Karma.

5.     Subjects who are ready to give written informed consent.

 EXCLUSION CRITERIA

1.     Age less than 18 years and greater than 60 years.

2.     Sthoulya associated with other known diseases like Diabetes Mellitus, Hypertension, hypothyroidism, cardiovascular diseases, hemiplegia and from other such disease in which the subjects cannot do his routine physical activities will be excluded.

3.     Sthoulya with Pregnancy and with other significant associated illness, and ongoing menstruation, subjects who will Having cortico-steroids, Oral contraceptive pills will be excluded.

INTERVENTION:

GROUP A: Yoga Basti: 8 Basti [CH.Si.1/48]                

NUMBERS OF BASTI

1

2

3

4

5

6

7

8

TYPES OF BASTI

AB

NB

AB

NB

AB

NB

AB

NB

GROUP B: Chaturbhadra Kalpa Basti Krama: 12 Basti [Kashyapa Khila Sthan 8-23]

NUMBERS OF BASTI

1

2

3

4

5

6

7

8

9

10

11

12

TYPES OF BASTI

AB

AB

AB

AB

NB

NB

NB

NB

AB

AB

AB

AB

 Here AB for – Anuvasana Basti; NB for – Niruha Basti

The effect of the Basti (Panchakarma therapy) will be assessed based on the following criteria

1.     Samyak Basti Lakshanas

2.     Retention time of Basti

3.     Number of purisha vega

4.     Possible complications after administration of Basti

5.     Vital data of patients

 
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