Clinical Study to assess the effectiveness of Lekhan Basti(enema therapy) in Yoga Basti Schedule and Chaturbhadra Kalpa Basti Schedule in sthoulya(obesity)
- Conditions
- Obesity, unspecified. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA),
- Registration Number
- CTRI/2022/05/042438
- Lead Sponsor
- Parul Ayurved Hospital
- Brief Summary
In the recent years, India is under siege of Junkfood, 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. Itsprevalence has increased threefold according to WHO estimation in 2016, morethan 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 strictlycontraindicated 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 itexpels the vitiated doshas rapidly and easily from body.
There aredifferent patterns explained like *Yoga* *Basti*, *Kala* *Basti*,*Karma* *Basti* and different research works have been carried out onthese three patterns but regarding *Chaturbhadra* *Kalpa* *Basti**krama* which is *Niratyaya* and can be givenin *Sukumara* which is mentioned in *Kashyap**Samhita*; there is less research work has been done. Therefore, it’sthe main reason to choose this pattern of *Basti* as it is mainlyindictaed in *Sukumara* as *Niratyaya*, which is easy as compared to *Vamana*and *Virechana* *Karma* and this *Basti* pattern having nocomplications than *Vamana* and *Virechana* *karma*, but whilethese two *Sodhana* *karmas* has more precautions that are needed to befollowed.
*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 Paediatricage 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 researchstudies and clinical practices can be done referring *Kasyapa* *Samhita*,which is omitted in today’s current research work and clinical practice inadults.
According to *Sharangadhara*and *Sushīruta* *Samhita* it is mentioned that first *Utkleshana*then *Doshahara* and in last *Samshamaneeya* *Basti* should begiven, in this way we can understand *Chaturbhadra* *Kalpa* *Basti**Krama*, as first 4 *Anuvasan*a may act as *Utkleshana* *Basti*next 4 *Niruha* *Basti* may act as *Doshahara* *Basti* andlast 4 *Anuvasan*a *Basti* may act as *Samshamaneeya* *Basti*.
STUDY DESIGN
AIM: A comparison theefficacy of *Lekhan* *Basti* in *Yoga* *Basti* *krama*and *Chaturbhadra* *kalpa* *Basti* *krama* in themanagement 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 *YogaBasti 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 iseffective 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, modernliteratures, journals, websites about the disease and drugs will be reviewedand documented for the planned study.
Pharmaceutical source: *Moorchhita Tila Taila*for *Anuvasan* *Basti* will be prepared in the GMP certified Pharmacyof Parul Institute of Ayurved.*Niruha* *Basti* will be prepared atParul 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 fromOPD and IPD of Parul Ayurveda Hospital, Parul University,and various HealthCheckup Camps.
DIAGNOSTIC CRITERIA: The patients willbe examined before *Basti karma* and after completing basti schedule.Changes in patient’s condition will be noted & following points will betaken in consideration for the assessment of the results.
INCLUSION CRITERIA
1. Subjecthaving signs and symptoms of *Sthoulya* explained in Ayurveda Text.
2. Agebetween 18 years to 60 years irrespective of gender, caste, religion.
3. Subjectshaving BMI between 25-40.
4. Subjectswho are fit for *Basti* *Karma*.
5. Subjectswho are ready to give written informed consent.
EXCLUSION CRITERIA
1. Ageless than 18 years and greater than 60 years.
2. *Sthoulya* associated with other known diseases likeDiabetes Mellitus, Hypertension, hypothyroidism, cardiovascular diseases,hemiplegia and from other such disease in which the subjects cannot do hisroutine physical activities will be excluded.
3. *Sthoulya* with Pregnancy and with other significantassociated illness, and ongoing menstruation, subjects who will Havingcortico-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
GROUPB: *Chaturbhadra* *Kalpa* *Basti* *Krama*: 12 *Basti* [Kashyapa KhilaSthan 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 – *Anuvasan*a *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. Retentiontime of *Basti*
3. Numberof *purisha vega*
*4.*Possible complications after administration of *Basti*
*5.*Vital data of patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Increase in quality of life and reduced the risk of lifestyle disorders in obesity patient for 15 to 30 days
Trial Locations
- Locations (1)
Parul Ayurved Hospital
🇮🇳Vadodara, GUJARAT, India
Parul Ayurved Hospital🇮🇳Vadodara, GUJARAT, IndiaAnjaliben Ramanlal GayakwadPrincipal investigator7990962473anjaligayakwad37@gmail.com