| CTRI Number |
CTRI/2016/01/006509 [Registered on: 11/01/2016] Trial Registered Prospectively |
| Last Modified On: |
07/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY OF GUNJAMULA(ROOT) ON HAIR FAL |
|
Scientific Title of Study
|
A Study on PHARMACO DYNAMICS and THERAPEUTIC of GUNJA MOOLA (ABRUS PRECTORIUS,Linn)with Special Reference to itsKESYA KARMA(TRICHOTONIC ACTION) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K MADHUSUDANA RAO |
| Designation |
ASST PROFESSOR |
| Affiliation |
|
| Address |
Dr.N.R.S.Govt.AYURVEDIC COLLEGE(BANDARLORD)MG ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Dr.N.R.S.Govt.AYURVEDIC COLLEGE(BANDARLORD)MG ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Krishna
ANDHRA PRADESH
5200002
India |
| Phone |
919441058500 |
| Fax |
0866-2576922 |
| Email |
drmadhu1117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M papramkusha rao |
| Designation |
PG professor & HOD |
| Affiliation |
|
| Address |
Department of Dravyaguna
S.V.Ayurvedic college
Tirupathi,A.P
Dr.N.R.S.Govt.AYURVEDIC COLLEGE(BANDARLORD)MG ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Krishna
ANDHRA PRADESH
517501
India |
| Phone |
919393608779 |
| Fax |
0866-2576922 |
| Email |
paramkusha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K MADHUSUDANA RAO |
| Designation |
ASST PROFESSOR |
| Affiliation |
|
| Address |
Dr.N.R.S.Govt.AYURVEDIC COLLEGE(BANDARLORD)MG ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Dr.N.R.S.Govt.AYURVEDIC COLLEGE(BANDARLORD)MG ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Krishna
ANDHRA PRADESH
5200002
India |
| Phone |
919441058500 |
| Fax |
0866-2576922 |
| Email |
drmadhu1117@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
dr MADHUSUDANA RAO self |
| Address |
Dr.N.R.S GOVT AYURVEDIC COLLEGE M.G ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr K MADHUSUDANA RAO |
Dr.N.R.S GOVT AYURVEDIC COLLEGE M.G ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR K MADHUSUDANA RAO |
DR N R S GOVT AYURVEDIC COLLE & HOSPITAL VIJAYAWADA |
Dr.N.R.S GOVT AYURVEDIC COLLEGERROOM NUMBER 4 DEPT OF KAYA CIKITSA GROUND FLOOR M.G ROAD BESIDE VIJAYA KRISHNA SUPER BAZAR VIJAYAWADA-2 ANDHRA PRADESH
Krishna
ANDHRA PRADESH |
9441058500
drmadhu1117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTES ETHIC COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENTS SUFFERING WITH LOSS OF HAIR |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GUNJAMULA FRESH DRUG PASTE (AYURVEDA) |
DOSE: DRUG PASTE DEPENDING UPON THE EFFECTED AREA
GUNGAMULA THAILA EXTERNAL APPLICATION DEPENFING UPON THE EFFECTED AREA
GUNJAMULA THALA FOR NASYAKARMA 4-TO 5 DROPS IN EACH NOSTRIL IN 40 DAYS |
| Comparator Agent |
GUNJAMULA PASTE FOR GROUP 1
IN 40DAYS
GUNJAMULA THAILA FOR GROUP 2IN 40DAYS
GUNJAMULA THAILA AS NASYA KARMA FOR GROUP 3 IN 40DAYS
|
DOSE: DRUG PASTE DEPENDING UPON THE EFFECTED AREA GROUP 1 GUNGAMULA THAILA EXTERNAL APPLICATION DEPENFING UPON THE EFFECTED AREA FOR GROUP 2 GUNJAMULA THALA FOR NASYAKARMA 4-TO 5 DROPS IN EACH NOSTRIL IN 40 DAYS FOR GROUP 3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
MALE & FEMALE PATIENTS WILLING FOR TREATMENT IN HAIR LOSS AGE FROM 18-50 YEARS
|
|
| ExclusionCriteria |
| Details |
PATIENTS SUFFERING WITH DIABETIS,HYPERTENSION GENETICAL BALDNESS PETIENTS SUFFERING FROM CHRONIC DISORDERS AND UNDER GOING MEDICATIONS OR DRUG AUTO IMMUNE DISORDERS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EXPECTING 0.5CM OF HAIR GROTH IN 6 WEEKS |
EXPECTING 0.5CM OF HAIR GROTH IN 6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EXPECTING IN THE 1CM OF HAIR GROWTH IN 6 WEEKS |
6 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/02/2016 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hair fall is a psycho somatic disorder.It has cosmetic value also. In the present days young people also suffering from hair falls. Artificial methods implied for hair growth are expensive and injurious. A natural and safe hair grower is the need of the hour. It is hoped that Gunja will stand as an answer for hair fall.
This study is randomized ,parallel group trail comprising the safety and efficacy of Gunja mula paste as external application and Gunja mula thaila as application application on effected area and Gunja mula thiala as nasal drops 4 to 5 drops per week
patients are divided in to 3 groups
Group 1: Gunja mula paste as local application depending upon the ares effected
Group2 : Gunja mula thiala extranal appliction as per the area effected
Group 3: Gunja mula thiala as pratimarsa nasya 4 to 5 drops per week in 40days
|