| CTRI Number |
CTRI/2021/04/033039 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the effect of
SanshodhanKarma i.e. Vaman and Virechan on lipid profile. |
|
Scientific Title of Study
|
A comparative clinical study to assess the effect of
SanshodhanKarma i.e. Vaman and Virechan on lipid profile. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
PG Dept of Panchkarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
PG Dept of Panchkarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Bapat |
| Designation |
Panchkarma Vaidya |
| Affiliation |
|
| Address |
PG Dept of Panchkarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955473435 |
| Fax |
|
| Email |
vaibhavajitbapat@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Jorahawar Singh gate Amer road Jaipur
302002 Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Gopesh Mangal |
National Institute of Ayurveda |
OPD room no 2 and IPD
of Panchakarma
Department , National
Institute of Ayurveda,
Jaipur 302002,
Rajasthan
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
300 relatively healthy individuals of either sex |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vaman Karma |
In group A Paachan with panchakolchurna 3gm for 7 days snehapaan with cow ghee in
increasing dosage starting dose with 50ml and 25ml dose will be increased daily till the
achievement of Samyaksnehalakshana.
In group A Vaman will be done with Aakanthapaan of milk, Vamak yoga will be
Madanfalpippalichurna 3gm, Kutajbeej churna 2gm, Patola patra 2gm madhu 10ml and saindhav
2gms, Madhuyashti faant with adequate quantity will be used as Vamanopag drug. |
| Comparator Agent |
Virechan Karma |
In group B Paachan with panchakolchurna 3gm for 7 days snehapaan with cow ghee in increasing dosage starting dose with 50ml and 25ml dose will be increased daily till the achievement of Samyaksnehalakshana.
In group B Triphala, Trivrit, Danti kwath 200ml will be given for Virechan. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female Subjects in the age group of 18 to 60 years, both inclusive.
2. Subjects who are willing to undergo sanshodhan karma.
3. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test
is required for all female subjects of childbearing potential unless subject has had a
hysterectomy, tubal ligation, or is > 2 years postmenopausal.
4. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an
informed consent form |
|
| ExclusionCriteria |
| Details |
1. Subjects with any known systemic disease.
2. Known cases of Severe/Chronic hepatic or renal disease.
3. Known case of any active malignancy.
4. Subjects giving history of significant cardiovascular event.
5. Subjects having known chronic, contagious infectious disease, such as active
tuberculosis, Hepatitis B or C, or HIV.
6. Pregnant and Lactating females.
7. Those who are contraindicated for sanshodhan karma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate changes in lipid levels after Ghritapan and Sanshodhan Karma. |
Blood samples for lipid profile will be collected for each individual. On the day before paachan
karma, on the day before commencement of Snehapaan, Next day of completion of snehapaan
and after completion of SansarjanKrama and followup 15 days after sansarjan karma. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the probable risk factors of Ghritapan and Sanshodhankarma on the basis of lipid
levels |
On the day before paachan
karma, on the day before commencement of Snehapaan, Next day of completion of snehapaan
and after completion of SansarjanKrama and followup 15 days after sansarjan karma. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
26/04/2021 |
| 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
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
300 relatively healthy individuals of either sex will be randomly divided in to two equal groups
namely group A and group B Group A individuals will undergo Vaman Karma and group B
individuals will undergo Virechan karma.
Blood samples for lipid profile will be collected for each individual. On the day before paachan
karma, on the day before commencement of Snehapaan, Next day of completion of snehapaan
and after completion of SansarjanKrama and followup 15 days after sansarjan karma.In both groups Paachan with panchakolchurna 3gm for 7 days snehapaan with cow ghee in
increasing dosage starting dose with 50ml and 25ml dose will be increased daily till the
achievement of Samyaksnehalakshana.
In group A Vaman will be done with Aakanthapaan of milk, Vamak yoga will be
Madanfalpippalichurna 3gm, Kutajbeej churna 2gm, Patola patra 2gm madhu 10ml and saindhav
2gms, Madhuyashti faant with adequate quantity will be used as Vamanopag drug.
In group B Triphala, Trivrit, Danti kwath 200ml will be given for Virechan.
Total expected duration of completion of this research trial will be approximately 3years. |