| CTRI Number |
CTRI/2021/05/033343 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRIHTYADI LEPA(Chakradatta)AND RAKTAMOKSHANA BY GHATI YANTRA IN CASES OF Hair fall |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRIHTYADI LEPA(Chakradatta)AND RAKTAMOKSHANA BY GHATI YANTRA IN CASES OF KHALITYA (w.s.r. to ANDROGENIC ALOPECIA) |
| Trial Acronym |
CSBLGYKA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Kumar Pandey |
| Designation |
MD Ayurveda research scholar |
| Affiliation |
State Ayurveda college and hospital lucknow |
| Address |
PG department of Kayachikitsa State Ayurveda college and hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
anil.edu88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anant Krishna |
| Designation |
Leturer |
| Affiliation |
State Ayurveda college and hospital lucknow |
| Address |
PG department of Kayachikitsa State Ayurveda college and hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
anant10patel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anant Krishna |
| Designation |
Leturer |
| Affiliation |
State Ayurveda college and hospital lucknow |
| Address |
PG department of Kayachikitsa State Ayurveda college and hospital Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
anant10patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurveda College and Hospital, Tulasidas Marg, Turiyaganj, Lucknow,U.P.-226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurveda College and Hospital Lucknow |
| Address |
State Ayurveda College and Hospital Tulasidas Marg Lucknow 226003 |
| Type of Sponsor |
Government 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 |
| Anil Kumar Pandey |
State Ayurveda College and Hospital |
Room No.25 Department of Kayachikitsa, State Ayurveda College and Hospital
Lucknow
UTTAR PRADESH |
9452861300
anil.edu88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC State Ayurvedic College And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brihatyadi Lepa by Chakradatta |
complete scalp hair removal (On patient consent) and 50 gm Brihatyadi lepa mix with plain water and applied on scalp twice in a week for one hour in normal climatic condition for 3 month |
| Comparator Agent |
Raktamokshana by Ghati Yantra |
patient will be asked to lie down in supine position on bed with straight legs & hands near the body. Ghati -yantra uses a rubber pump to create the vacuum inside the cup. During wet cupping, a mild suction is created using a cup that is left in place for about three minutes, this causes the skin to rise and redden as blood vessels expand. Then removes the cup and uses a small scalpel or lancet make superficial skin incisions. After that performs a second suction for 5-10 minutes to draw out a small quantity of blood. Raktamokshna perform twice in a month for 3 month. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
A-SUBJECTIVE PARAMETERS-
1 Patients who give the consent to participate in clinical trial.
2 Patients of age group 21-40 years.
Essential Criteria–Gradual hair fall, more than 100 hairs par day in a couple of weeks.For males, the pattern typically involves loss of the frontal hairline with hair loss at the vertex (or top of the scalp) and progress over time. For females, the pattern is more variable, but most often spares the frontal hairline and involves diffuse thinning of hair over the crown of the scalp, sparing the back. This again progress over time.
Non-Essential/Others Criteria
a.Darunaka (Dandruff)
b.ShirahKandu (Itching on scalp)
c.Kesh Tanutva (Thinning of Hairs)
d.Kesh Rukshta (Dryness of Hair)
e.Kesh Bhoomi Sweda (Sweating on Scalp)
B-OBJECTIVE PARAMETERS
a. Total Number of hair loss/day
b.After sleep numbers of hairs on Pillow
c.During hair wash number of hairs
d.During combing hair number of hairs
e.Hair pull test
f.Hormone test -testosterone
Patients having Essential criteria along with minimum 50% of Non-essential parameter will be registered for clinical trial.
|
|
| ExclusionCriteria |
| Details |
1 Cases of any chronic systemic disorders
2 Thyroid disorder
3 Traumatic hair loss
4 Burns,
5 chemotherapy
6 Bacterial Infection
7 Localized surgery
8 Cases with family history of Alopecia.
9 More than 75% hair loss.
10 Age below 21 year & above 40 year
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate clinical efficacy of Brihatyadilepa in Khalitya.
2 To evaluate clinical efficacy of Raktamokshna by Ghati-Yantra in Khalitya.
3 Comparative efficacy between Lepan Karma and Raktmokshna.
4 To evaluate cumulative effect of Lepa & Raktamokshna
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the adverse effect of drug if any.
2 To provide scientifically proved,effective management in Khalitya
|
3 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/05/2021 |
| Date of Study Completion (India) |
20/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Review of Brihatyadi lepa and Raktamokshana by Ghati Yantra (Cupping Therapy) in Khalitya |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TYPE OF STUDY- Phase-2, randomized and parallel group study. PERIOD OF STUDY Total duration of clinical Trial is of 3 months FOLLOW UP PERIOD Follow up of all registered patients will be of one month after the treatment is completed. SELECTION OF CASES For the purpose of present clinical trial,cases of Khalitya (Androgenic Alopecia ) will be selected regardless of sex occupation, socioeconomic condition& religion in the age group of 21- 40 years from the OPD / IPD of State Ayurvedic College & Hospital Lucknow. After clinical examination, History &Lab investigation patients fulfilling the inclusion criteria and exclusion criteria will be enrolled for the clinical trial. SAMPLE SIZE Minimum of 60 patients will be selected from OPD/ IPD of State Ayurvedic College & Hospital Lucknow & refered cases from other Hospitals, divided randomly into 3 Groups i.e. Group A, Group B & Group C with approximately 10% drop out. Group A In this Group patients will be treated with Brihatyadi Lepa, twice in a week for 3 months (24 sittings). Group B In this Group patients will be treated with Raktamokshna by Ghati-Yantra at the interval of 10 days for 3 months ( 9 sittings ). Group C In this Group patients will be treated with Brihatyadi Lepa and Raktamokshna by Ghati- Yantra as above for 3 months. |