| CTRI Number |
CTRI/2023/05/052623 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
STUDY TO ASSESS THE EFFECT OF
GUNJA TAILA ALONE AND IN COMBINATION WITH PIPPALYADI
AGADA IN THE MANAGEMENT OF DOOSHIVISHAJANYA KHALITYA |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO ASSESS THE EFFECT OF
GUNJA TAILA ALONE AND IN COMBINATION WITH PIPPALYADI
AGADA IN THE MANAGEMENT OF DOOSHIVISHAJANYA KHALITYA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VICHI SHARMA |
| Designation |
MD SCHOLAR AGADTANTRA DEPARTMENT |
| Affiliation |
Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal, MP 462003 India |
| Address |
Room no.228, PG Department of Agadtantra, Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal
PG Department of Agadtantra, Pt Khushilal Sharma Govt Auto Colg and Institute
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9340059138 |
| Fax |
|
| Email |
drvichi24sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR URMILA SHUKLA |
| Designation |
PROFESSOR & HOD AGADTANTRA DEPARTMENT |
| Affiliation |
Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal, MP 462003 India |
| Address |
Room no.228, PG Department of Agadtantra, Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425672655 |
| Fax |
|
| Email |
urmila.shukla.393950@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VICHI SHARMA |
| Designation |
MD SCHOLAR AGADTANTRA DEPARTMENT |
| Affiliation |
Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal, MP 462003 India |
| Address |
Room no.228, PG Department of Agadtantra, Pt Khushilal Sharma Govt Auto Colg and Institute, Bhopal
PG Department of Agadtantra, Pt Khushilal Sharma Govt Auto Colg and Institute
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9340059138 |
| Fax |
|
| Email |
drvichi24sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Govt Auto Ayurveda Collg and Institute Bhopal MP |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt Auto Ayurveda Collg and Institute Bhopal MP |
| Address |
Pt Khushilal Sharma Govt Auto Ayurveda Collg and Institute Bhopal MP |
| 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 Vichi Sharma |
pt khushilal sharma govt. autonomous ayurveda college and institute , bhopal |
department of Agadtantra, pt khushilal sharma govt. autonomous ayurveda college and institute , bhopal
Bhopal
MADHYA PRADESH |
9340059138
drvichi24sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt. Khushilal Sharma Govt. Ayurveda Institute, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L648||Other androgenic alopecia. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | shiroabhyanga | (Procedure Reference: vagbhata, Procedure details: shiroabhyanga)
(1) Medicine Name: gunja taila, Reference: chakradutta kshudra rogadhikara 9/90, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: sos, Duration: 45 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: pippalyadi agada, Reference: yogratrnakar vishachikitsa 10, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: -(2) Medicine Name: gunja taila, Reference: chakradutta kshudra rogadhikara 9/90, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -shiroabhyanga | | 3 | Comparator Arm (Non Ayurveda) | | - | placebo | roasted semolina filled capsule 1 BD |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 16 to 45 years of either sex with the complaint of khalitya will
be selected irrespective of cast, creed, religion, occupation, habitat etc.
2. Patient provides informed consent prior to initiation of study procedure and is
willing to join the study. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 16 years and above 45 years.
2. Patients suffering from systemic illnesses.
3. Patients having area of hair loss on the scalp because of any injury to the head.
4. Patients having hereditary of Baldness.
5. Patients diagnosed to have local scalp diseases like Alopecia.
6. Pregnant and Lactating women.
7. Patient who is not willing to join the clinical study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study we would be able to demonstrate the efficacy of gunja taila alone and in combination with pippalyadi agada in the management of dooshivishajanya khalitya
efficacy of Gunja taila alone and in combination with Pippalyadi Agada in the
management of dooshivishajanya Khalitya. |
60 DAYS AFTER STARTING OF INTERVENTION. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to improve quqlity of life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2023 |
| 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
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1) For the clinical study on khalitya, patients fulfilling the criteria of diagnosis and criteria for inclusion of present study from OPD and IPD of Pt. Khushilal Sharma Govt Ayurveda College and Institute Bhopal (MP) 2) Study Design - The study will be designed as a Randomized controlled clinical trial and sample will be selected by simple random technique. 3) Sample Size - Study will be conducted on 60 patients divided into 3 groups of 20 patients each. 4) Study Duration - 45 days 5) Follow up - In every 15 days for duration of treatment and 15 days after completion of treatment.
|