| CTRI Number |
CTRI/2017/06/008816 [Registered on: 12/06/2017] Trial Registered Prospectively |
| Last Modified On: |
08/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimba Beeja Taila On Vipadika. |
|
Scientific Title of Study
|
A Study To Evaluate The Efficacy of Nimba Beeja Taila On Vipadika. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashvini Vitthal Kamble |
| Designation |
BAMS MD scholor samhita dept. |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rasta peth pune,411011 |
| Address |
C/O Prof. Kamble V.M
Yashwant nagar Murum.
Tq Omerga Dist Osmanabad
pin 413605
Tilak Ayurved Mahavidyalaya Rasta Peth Pune 411011
Pune
MAHARASHTRA
413605
India |
| Phone |
7722067056 |
| Fax |
|
| Email |
Dr.ashvini33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashvini Vitthal Kamble |
| Designation |
BAMS MD scholor samhita dept. |
| Affiliation |
Tilak Ayurved Mahvidyalaya |
| Address |
583 2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
7722067056 |
| Fax |
|
| Email |
Dr.ashvini33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Ramchandra Joshi |
| Designation |
Associate Proffessor samhita siddhant dept. |
| Affiliation |
Tilak Ayurved Mahavidyalaya Rasta peth pune,411011 |
| Address |
583 2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9822435536 |
| Fax |
09822435536 |
| Email |
manvantar@gmail.com |
|
|
Source of Monetary or Material Support
|
| sample is collected from Local vender in pune .The sample is standardize in Bhide Foundation and
Authenticate in Agarkar Institute of Research . |
|
|
Primary Sponsor
|
| Name |
Ashvini vittthal kamble |
| Address |
Tilak Ayurved Mahavidyalaya |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mohan R Joshi |
Tilak Ayurved Mahavidyalaya pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashvini Vitthal Kamble Dr Mohan R Joshi |
Sheth Tarachand Ramnath Dharmarth Ayurved Hospital,Pune |
Tilak Ayurved Mahavidylaya
Sanskrit Samhita Siddhanta Dept Rasta peth pune 411011
Pune
MAHARASHTRA |
7722067056
Dr.ashvini33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tilak Ayurved Mahavidyalaya |
Approved |
| Institutional Ethics Committee Tilak Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cracked feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimba Beeja Taila |
as per refrence in Ayurved Samhita
Ashtang hridya su.5/60
Dose minimum 10 drops (sos)
Route of administration-Externally (local Application)
Frequency of route of administration -once a day
Total duration of therapy-7days
|
| Comparator Agent |
Til Taila |
As per reference in Ayurved Samhita.
Dose - minimum 10 drops (sos)
Route of administration-Externally(local appliction)
frequency of route of administration-once a day
Total duration of therapy- 7days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients will be selected irrespective of sex & religion above the age of 18 years.
2)All patients showing dryness and roughness of feet above no.4 on visual analogue scale.
3)Patients willingly participating in study trial from Seth. Tarachand Ramnath Charitable hospital.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION-
1)Patients of age group below 18 years.
2)Patients taking oral medication which can interfere with the snehan.
3)Patients having any infectious, inflammatory condition.
4)Patients having febrile condition.
5)Patients contraindicated for abhyang like kaphaj vyadhit, sanshodhit, suffering from indigestion .
6)Patients suffering from dryness by diseased conditions like psoriasis,etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the clinical symptoms |
Decreased dryness and roughness of feet. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the clinical symptoms |
Disappearance of minute cracks of feet |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3 |
|
Date of First Enrollment (India)
|
26/06/2017 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Kushthghna effect of Nimba beeja Taila is described in the Ashtang Hridya Sutra sthana Adhyay no.5. In Ayurveda the disease Vipadika is explained under “Kshudra kushta†where it is due to excessive walk etc., the aggravated dryness (ruksha gun) of vata produces painful cracks in foot. Abhayanga with the various sneha dravyas(oil) is the most used best remedy for the vata roga which is commonly practiced in the treatment of vipadika. Nimba beeja taila has tikata, ushna, laghu, snigdha and kushthaghna gun which increases the activity of oil as vatashamana and kushthaghana property when it is used for padabhayanga i.e, oil massage. As per mentioned in Dincharya head, ear and feet should be specially massaged . Feet are vulnerable to dryness and roughness due to daily friction while walking. Hence for the purpose of this study feet are selected for massage as it is most exposed part of the body Kushthaghna action of Nimba beeja will be enhanced by formulation in form of oil. it can reduce time, quantity of drug and will provide prolong relief even after same duration of treatment. Sample size of study is 44 and duration of study is 7 days follow up upto 30 days. Study Design: randomized single blind controlled study. |