| CTRI Number |
CTRI/2022/11/047781 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sadyasnehapan with bahusneha ksheerpeya to observe samyak siddhi lakshanas(signs of internal oleation) within 3days of administration |
|
Scientific Title of Study
|
A clinical study to observe the effect of bahusneha ksheerpeya for sadyo snehana with respect to samyak snigdha lakshanas within 3 days |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Maruti Hule |
| Designation |
PG(sch) |
| Affiliation |
PDEAs College of Ayurveda and research Centre Nigadi,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre
3rd floor Panchakarma department sector 25 Pradhikaran ,Nigadi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8806726668 |
| Fax |
|
| Email |
sonali.hule1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pournima Daware |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of Ayurveda and Research centre nigadi |
| Address |
PDEAs College of Ayurveda and Research Centre
3rd floor Panchakarma department sector 25 Pradhikaran ,Nigadi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9762561688 |
| Fax |
|
| Email |
rikibepournima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pournima Daware |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of Ayurveda and Research centre nigadi |
| Address |
PDEAs College of Ayurveda and Research Centre
3rd floor Panchakarma department sector 25 Pradhikaran ,Nigadi ,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9762561688 |
| Fax |
|
| Email |
rikibepournima@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of Ayurveda and Research centre Nigadi,Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurveda and reseach centre Nigadi,pune |
| Address |
PDEAs College of Ayurveda and Research Centre
3rd floor Panchakarma department sector 25 Pradhikaran ,Nigadi ,Pune |
| Type of Sponsor |
Private 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 Sonali Maruti Hule |
Ayurveda Rugnalay and Sterling Multispeciality Hospital , Nigadi |
Panchakarma OPD NO-21
Pune
MAHARASHTRA |
8806726668
sonali.hule1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INDIVIDUAL FIT FOR SHODHAN KARMA AND WHO WILL FULLFILL CRITERIA FOR SNEHAPAN ARHATA |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sadyasnehaH , सदà¥à¤¯à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: sushruta samhita chikitsa sthana 31/16, Procedure details: Administration of Bahusneha ksheerpeya for abhyantar sneha pana as a sadyo-sneha upto 3 days to observe samyak sneha siddhi lakshanas .
drug- bahusneha ksheerpeya
dose -will be decided on the basis of agni and koshta (approximately dosage will be 120 for mrudu koshtaa ,150 for madhyam koshta and 200 for krur koshta)
duration - 3 days
seval kal -prabhate abhkta avastha
frequency OD
)
(1) Medicine Name: bahusnhea ksheer peya, Reference: A.H su 16/39-42, Route: Oral, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
SNEHAPANA YOGYA
SHODHAN YOGYA
|
|
| ExclusionCriteria |
| Details |
SEVERE IMPAIRMENT OF AGNI
CARDIAC DISEASES
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHETHER SAMYAK SNEHAPAN SYMPTOMS (signs of internal oleation)OBSEREVED WHEN BAHUSNEHA KSHEERAPEYA IS ADMINISTERED FOR SADYOSNEHAPANA FOR 3 DAYS |
DAILY FOLLOWUP upto 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FIXATION OF DOSE OF BAHUSNEHA KSHEERPEYA FOR SADYASNEHAPAN ON THE BASIS OF AGNI AND KOSHTA AFTER ALL OBSERVATIONS ARE MADE |
3 DAYS OBSERVATIONS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Now a days there is huge rise in cases of lifestyle disorders which can be very well treated with the Ayurveda panchakarma tretments . In present days it is observed that though many of the patients require shodhana and many healthy individuals are willing for shodhana it is difficult to perform shodhana due to lack of time ,as the period of 5-7 days is required to achieve samyak snigha lakshanas .In such scenarios sadyo snehapan i.e. administration of sneha dravya for shorter duration will be very helpful. Sadyo snehana means shigrah snehana. Many references regarding sadyo snehapan yogas are mentioned but their dosage,duration and method of administration is not clearly mentioned. This study is aimed to observe if we can achieve sneha siddhi lakshanas within shorter span with help of sadyosnehapana method and the dosage for bahusneha ksheerpeya asper agni and kosthta . |