| CTRI Number |
CTRI/2023/05/052506 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Pracchana Karma And Shudha Langalimool Kalka Lepa With Platelet Rich Plasma Therapy In The Treatment Of Alopecia(Indralupta) |
|
Scientific Title of Study
|
To Study The Effect Of Pracchana Karma (Micro-Needling) And Shudha Langalimool Kalka Lepa In Comparison To Platelet Rich Plasma Therapy In The Management Of Indralupta (Alopecia). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rajesh Sood |
| Designation |
Head of Department |
| Affiliation |
Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 405 Department of Samhita and Siddhanta, Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh Sood |
| Designation |
Head of Department |
| Affiliation |
Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 405 Department of Samhita and Siddhanta, Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418102424 |
| Fax |
|
| Email |
drrajeshsood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Bhardwaj |
| Designation |
P.G. Scholar |
| Affiliation |
Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola |
| Address |
Department of Samhita and Siddhanta, Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018976093 |
| Fax |
|
| Email |
bhardwaj77garima@gmail.com |
|
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Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayu college and hospital Paprola, Kangra, H.P. |
|
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Primary Sponsor
|
| Name |
RGGPG Ayurvedic College,Paprola |
| Address |
Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Samhita and Siddhanta, Rajiv Gandhi Government P.G. Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Rajesh Sood |
Rajiv Gandhi Government P.G. Ayurvedic College |
OPD No.715 Skin Care Unit and Derma Research Lab
Rajiv Gandhi Government P.G. Ayurvedic College and Hospital Paprola
Kangra
Himachal Pradesh
Kangra
HIMACHAL PRADESH |
09418102424
drrajeshsood@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) RGGPG Ayurvedic college Paprola |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L63||Alopecia areata. Ayurveda Condition: KHALITYAM/KHALATI, (2) ICD-10 Condition:L64||Androgenic alopecia. Ayurveda Condition: KHALITYAM/KHALATI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pracCAnam, पà¥à¤°à¤šà¥à¤›à¤¾à¤¨à¤®à¥ | (Procedure Reference: A.S.U.28/88,89, Procedure details: Area is cleaned.
Pracchana Karma is done.
Repeated after 21 days three times)
(1) Medicine Name: shudha langalimool kalka lepa, Reference: A.S.U.28/88,89, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: sos, Duration: 3 Months | | 2 | Intervention Arm | Procedure | - | pracCAnam, पà¥à¤°à¤šà¥à¤›à¤¾à¤¨à¤®à¥ | (Procedure Reference: A.S.U.28/88-89, Procedure details: Area is cleaned.
Pracchana Karma is done.
Repeated after 21 days three times.)
| | 3 | Comparator Arm (Non Ayurveda) | | - | Platelet Rich Plasma Therapy | Platelet-rich plasma (PRP) means “abundant platelets that are concentrated into a small volume of plasma.
Inter-follicular injection of PRP at the amount of 0.05-0.1 ml/cm2, in a retrograde fashion from deep to superficial, at every centimeter, throughout the affected site.
consist of 3 sessions which are done at interval of 21 days.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient showing signs and symptoms of the disease Indralupta /Alopecia.
2.Patients willing and able to participate in the trial.
3.Patients between 18-60 years of age irrespective of gender, religion and occupation will be selected for the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient below 18 and above 60 years.
2.Patient who are suffering from any serious conditions like cardiac disease, hypertension, diabetes, malignancy or infectious diseases such as T.B.
3.Low platelet count or any platelet dysfunction.
4.Patient taking anti-coagulants and anti-platelets.
5.Patients with chronic skin diseases.
6.Patients showing positive KOH will be excluded.
7.Pregnant and lactating females.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Overall improvement which will be shown by the patients in the signs and symptoms of the disease. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Growth of hair in the bald patch. |
63days |
|
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Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Hair is considered as one of the most important measures of beauty. In today’s era, hair related problems are increasing due to various internal and external factors. One such problem of concern is alopecia. Alopecia simply means loss of hair from scalp or elsewhere on the body. In Ayurveda it can be co-related with Indralupta. In Ayurveda many different procedures have been explained. Acharya Vagbhatta indicated one such procedure known as the Pracchana Karma for the treatment of Indralupta. This study is aimed to assess the effectiveness of Pracchana Karma followed by Langalimool Kalka Lepa application in the management of Indralupta and then to compare the results of both the groups with that of platelet rich plasma therapy.
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