| CTRI Number |
CTRI/2019/05/019076 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Weight gain effectivity of balamoola with vidarikand in atikrusha. |
|
Scientific Title of Study
|
Randomized controlled clinical study of brimhaneeya effect of balamoola with vidarikand in atikrusha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Laxmanrao Hake |
| Designation |
PG final year |
| Affiliation |
PDEAs college of ayurved and research centre |
| Address |
collge of ayurveda and research centre samhita siddhant department pradhikaran nigdi sector no 25 pune 411044
Ayurved rugnalay and sterling multi speciality hospital sector no 27 pradhikaran nigdi pune department kaychikitsa OPD no 117 pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9623117655 |
| Fax |
|
| Email |
neetanashik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Khandalikar |
| Designation |
Associate Professor at samhita siddhant department |
| Affiliation |
PDEAs collage of ayurveda and research centre |
| Address |
collage of ayurved and research centre nigdi pradhikaran sector no 25 pune basic principle and samhita siddhant department
CARC Akurdi pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9860355409 |
| Fax |
|
| Email |
sandeep.khandalikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Laxmanrao Hake |
| Designation |
PG second year |
| Affiliation |
PDEAs collage of ayurveda and research centre |
| Address |
collage of ayurved and research centre nigdi pradhikaran sector no 25 pune basic principle and samhita siddhant department
CARC Akurdi pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9623117655 |
| Fax |
|
| Email |
neetanashik@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs collage of ayurved and research centre sector no 25 pradhikaran nigdi pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs collage of ayurved and research centre |
| Address |
Sector number 25 Pradhikaran Nigdi Pune 411044 |
| 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 Neeta Hake |
PDEAs collage of ayurved and research centre |
Ayurved rugnalay and sterling multi speciality hospital sector no 27 pradhikaran nigdi pune department kaychikitsa OPD no 117 ground floor pune 411044
Pune
MAHARASHTRA |
9623117655
neetanashik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commmitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Atikrusha |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balamoola churna |
group B of 32 subjects havibg BMI below 18.5 and symptoms of atikrusha will be administrated with Balamoola churna 3gm with water at morning for 3 months and final result will be compared with group A |
| Intervention |
Vidarikanda churna |
group A of 32 subjects havibg BMI below 18.5 and symptoms of atikrusha will be administrated with vidarikand churna 3gm with water at morning for 3 months and final result will be compared with group B |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
subjects having BMI below 18.5 and symptoms of atikrusha. |
|
| ExclusionCriteria |
| Details |
known case of HIV,Tuberculosis,Hyperthyroidism, Malignancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO OBSERVE EFFICACY OF BOTH THE DRUGS in subjects having bmi below 18.5.
to compare brimhaneeya effect of vidarikand and balamoola churna in atikrusha for 3 months with every month follow up. |
TO OBSERVE EFFICACY OF BOTH THE DRUGS in subjects having bmi below 18.5.
to compare brimhaneeya effect of vidarikand and balamoola churna in atikrusha for 3 months with every month follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to observe adverse effect if any.
2. to study brimhaneeya of vidarikand and balamoola. |
3 months with every month follow up. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
07/07/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vidarikand and Bala are described in brimhaneeya
maha kshaya in charak samhita. It
has properties of brimhan karma.
Leanness is the condition of being excessively krusha. Charakacharya described atikrush as the person has wasting up buttocks, abdomen and neck,
prominent vascular network, thin skin and bone and thick nodes. Maintaining a
weight below ones ideal weight range possess a number of risks. Including increased risk for infection anaemia , osteoporosis
and other conditions.
Brimhaniya maha kashya is a group of herbs which is supposed to be having influence on
metabolic functions. Probable mode of action of brimhan have predominance of guru,
snigdha,sheeta and mand guna ,madhur
rasa, madhur vipak causing brimhan
effectThe
conditions or disease in which the body of person become emaciated, having less
quantity of Rasdhatu further causing
a status of mauns hinata or mauns kshayam. According to acharya charaka intake of food in less
quantity is prime factor producing leanness and weight loss maunskshayam or weight loss means person
having krushata or thin body
personality it means in this condition brimhan
has been advocated in the classic for this management.
oporosis
and other conditions.
Brimhaniya maha kashya is a group of herbs which is supposed to be having influence on
metabolic functions. Probable mode of action of brimhan have predominance of guru,
snigdha,sheeta and mand guna ,madhur
rasa, madhur vipak causing brimhan
effect |