| CTRI Number |
CTRI/2012/08/002932 [Registered on: 29/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of medicated enemas on metabolic and immunological markers in patients suffering from obesity |
|
Scientific Title of Study
|
A prospective, assessor blind, open, parallel group study to observe the effects of Basti procedure (medicated enemas) on selected metabolic and immunological markers in patients suffering from Sthoulya (Obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 2; Date 21/06/2007 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urmila Thatte |
| Designation |
Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, MS Building, 1st Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
02224133767 |
| Fax |
|
| Email |
urmilathatte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urmila Thatte |
| Designation |
Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, MS Building, 1st Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai
MAHARASHTRA
4000012
India |
| Phone |
02224133767 |
| Fax |
|
| Email |
urmilathatte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urmila Thatte |
| Designation |
Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Clinical Pharmacology, MS Building, 1st Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai
MAHARASHTRA
4000012
India |
| Phone |
02224133767 |
| Fax |
|
| Email |
urmilathatte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal Science Advisor Prime Minister Office Govt of India |
|
|
Primary Sponsor
|
| Name |
Principal Science Advisor Prime Minister Office Govt of India |
| Address |
Office of Principal Scintific Adviser to the GOI
Vigyan Bhavan Annxe,
Maulana Azad Road,
New Delhi 110011 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhada Chiplunkar |
Advanced Centre for Treatment, Research & Education in Cancer (ACTREC) |
Tata Memorial Centre, Kharghar, Navi Mumbai 410 208
Mumbai
MAHARASHTRA |
02227405032
02227412894
schiplunkar@actrec.gov.in |
| Dr Raman Ghungarakar |
RA Podar Ayurvedic Medical college and MA Podar Ayurvedic Hospital |
Ground floor, Hospital Building, Dr. Anniee Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA |
9221100630
ghungralkar@rediffmail.com |
| Dr Renuka Munshi |
TNMC and BYL Nair Charitable Hospital |
Department of Clinical Pharmacology, 5th Floor, G building, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA |
02223014713
02223050347
admin@dcpnairhospital.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee R.A.Podar Medical College (Ayurvedic) and M.A.Podar Hospital |
Approved |
| Institutional Ethics Committee,TNMC & BYL Nair Ch. Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Basti (a course of Medicated enemas) |
Anuvasan Basti (enemas with medicated oils)quantity will be 240 ml per session, Asthapan Basti (enemas with plant decoctions)in the quantity of 960 ml per session. This treatement is given to patients for a total of 16 days through anal route. |
| Comparator Agent |
Not Applicable |
since it is difficult to employ an appropriate comparator for a therapeutic procedure such as enema, an open label study (without a control group) was carried out where pre-intervention and post-intervention variables were compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of Sthaulya i.e. having classical signs and symptoms of Sthoulya58 like
i. Mansmedo ati vridhi will be determined by following criteria.
a. BMI more than 30
b. Waist hip ratio more than 0.9.
ii. Sphik stana udar lumbanam: Pendular movement of breast, thighs, abdomen.
iii. Ayathoupchayo utshaah: Inability and non-willingness to carry out the work enthusiastically in spite of physically being capable to do so.
2. Patient is ready to abide by trial procedures and to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patient requiring acute medical care.
2. Patient having BMI less than 30 kg/m2
3. Disease related to Annava-Purishavahastrotasas (Ajeerna, Atisara, Aruchi, Chhardi, Pravahika, Amadosha, Mandagni, Arsha, Baddagudodara) and pranavahatrotasas (kasa, Swasa, Hikka).
4. Patient with multi-organ involvement, cardiac, respiratory, hepatic and renal disease.
5. Patients with Peet sneha, Garpeeta, Urusthambha, Galganda, Apachi, Shleepada.
6. Pregnant or lactating women (in women of child bearing age, a urine pregnancy test will be performed to rule out pregnancy).
7. Patient who has experienced panchakarma Vyapad (unwanted effects/ complications previously).
8. Patient who has received any of the Panchakarma procedure in last 2 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in metabolic and immunological status of the patients |
0 day, immediately after completion of procedures and 90 days after completion of procedures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical signs and symptoms of Sthaulya (Obesity) |
0 day, immediately after completion of procedures and 90 days after completion of procedures |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Manuscript prepartion is in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obesity, characterized by abnormal or excessive fat accumulation impairing health, is defined by the World Health Organization (WHO) as a Body Mass Index (BMI) equal to or more than 30kg/m2. Ayurveda, the Indian traditional medicine system has described Panchakarma i.e. “five procedures†[including Vamana (induced emesis), Virechana (induced purgation), Anuvasana Basti (medicated enema with oils), Niruha Basti (medicated enema with decoction) and Nasya (nasal instillation of medicines)] as therapeutic modalities. These procedures are widely practiced by Ayurvedic physicians and are extremely popular among patients as an intervention for many disorders especially life-style disorders including obesity where basti is the recommended procedure. The indications and contra-indications for basti therapy as well as the probable mechanism behind the multi-systemic effect of the procedure have been well documented in Ayurveda. An exhaustive literature search did not reveal any reports on the effects of Panchakarma on patho-physiological alterations in obesity. Hence, this clinical study was planned to explore whether a course of basti has any effect on the metabolic and immunological status in obese individuals. The study did not aim at evaluating efficacy of the intervention. Additionally, since it is difficult to employ an appropriate comparator for a complex therapeutic procedure such as panchakarma, an open label study (without a control group) was carried out where pre-intervention and post-intervention variables were compared. The recruitment of patients and collection of blood samples was done at RA Podar Medical (Ayu) College and MA Podar Ayurvedic Hospital. The Ethics Committee of that Institute ( RA Podar Medical (Ayu) College and MA Podar Ayurvedic Hospital) oversaw the project. ACTREC did immune functions under the oversight of the same EC
A total of 48 fulfilled eligibility criteria and were recruited in the study. 32 participants completed the study while 16 droped out from the study. The subject was under observation for a total of 138 days after being recruited in the study. The day Sample 1 (S1) was collected was designated as Day 0, S2 was collected on Day 48 (16 basti days and 32 days of life style and diet restrictions) and S3 on Day 138. |