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CTRI Number  CTRI/2025/01/079628 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison between GFC and Prachana in the management of male pattern Hairloss 
Scientific Title of Study   Comparative Clinical Study To Evalute The Efficacy Of Prachanna Followed By Guduchi Taila Shirobhyanga And Growth Factor Concentrate Therapy On Khalitya (Male Pattern Alopecia) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANDEEP M 
Designation  PG SCHOLAR 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Dept Of Pg And Ph D Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center

Koppal
KARNATAKA
583231
India 
Phone  9113939951  
Fax    
Email  sandeepsudeep1604@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VEERAYYA R HIREMATH 
Designation  PROFESSOR & HOD 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Dept Of Pg And Ph D Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR VEERAYYA R HIREMATH 
Designation  PROFESSOR & HOD 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Dept Of Pg And Ph D Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal  
 
Primary Sponsor  
Name  DEPARTMENT OF PG AND Ph D STUDIES IN SHALAKYA TANTRA 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep M  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital  Department of PG and PhD. Studies in Shalakya Tantra
Koppal
KARNATAKA 
9113939951

sandeepsudeep1604@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L649||Androgenic alopecia, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, (2) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pracCAnam, प्रच्छानम् pradhana karma is prachanna (Procedure Reference: Thakral Kewal Krishna Sushruta Samhita Chaukhambha Publication Reprint2017Su Chi 20 24 26 Dalhan, Procedure details: Prachchanna with dermaroller monthly once for two months )
(1) Medicine Name: Guduchi taila, Reference: r Indradeva Tripathi Editor Prof Ramanath dwivedy Chakradatta of Sri Chakrapanidatta with the Vaiayaprabha Hindi Commentary Chaukambha sanskrit sansthan Varanasi Chikitsa Sthana 107, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 60 Days
2Comparator Arm (Non Ayurveda)-Growth factor concentrate therapypresent study was conducted to determine the role of growth factor concentrate GFC therapy a modified platelet rich plasma PRP technique for the management of androgenetic alopecia In this study patients diagnosed with androgenic alopecia were treated with subcutaneous injections of GFC in the scalp A total of 2 sittings monthly once for two months were administered 4 weeks apart and the patients were followed up for 60days The treatment outcomes were assessed by taking global macroscopic photographs trichoscopic photomicrographs
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Patients having the classical clinical features of Khalithya
Patients who have Male pattern alopecia
Norwood Hamilton Scale up to G3 vertex
 
 
ExclusionCriteria 
Details  Alopecia totalis
Alopecia aerata
Tinia capitis
Aroomshika
Patients suffering from systemic diseases like anemia cancer diabetic mellitus rheumatological disorders SLE Hypertension
Patients with history of NSAIDs and Anti platelet drug within 120 hours of procedure and systemic corticosteroids within last 2 weeks Corticosteroid injection at treatment site within one-month Covid-19 Serology positive patients platelet dysfunction syndrome Thyroid disorders cardiac complaints
Norwood Hamilton Scale from G5-G8
Local infection at sight of procedure,
Hb-less than 10g/dl, platelet count less than 105000/ml
Tobacco and alcohol use 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Asessing Hair Growth in Male Pattern hairloss  120 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction hair folicles in male pattern hairloss  120 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   02/02/2025 
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="2"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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)?  

Response - NO
Brief Summary  
Kesha is the mala of asthi dhatu. It is originated from pitrujabhava during garbhavastha and also one amongst the factor for assessment of prakriti of a person, and beauty of an individual. The gradual loss of hair is referred as Khalitya. Prakupita Pitta combines along with Vata and takes Sthana samshraya in Romakupa and results in hairfall. Thereafter Shleshma along with Shonita obstructs the channel of Romakoopa leading to the stoppage of the regeneration of hair and this condition is known as Khalitya. The treatment modalities of Khalitya includes Shiro Abyanga, Prachanna, Lepa, Nasya and Shodhana chikitsa.

85% of men and 33% of women are affected with hair loss across the globe. Androgenic alopecia is the most common type of hair loss with prevalence of 95%. The proportion of men with moderate to extensive Male pattern hair loss was 42% at age of 18 to 49 years. Topical minoxidil, oral administration of finasteride and hair transplantation are the mode of treatment which are not free from side effects. GFC is one of the safe treatment protocol in present era for androgenic alopecia.

Pracchana is a type of shastrakruta raktamokshana which helps to remove the vitiated rakta and kapha dosha which obstructs the hair root, enhance the efficacy of absorption of taila, helps to improve the perifollicular vascularization and strengthens the hair follicle. Guduchi taila has kesha ropana property and Yashtimadhu & amalaki churna have keshya property.

With these facts, the present study has been taken to compare the efficacy of Prachanna followed by Guduchi taila Shirobhyanga with internal administration of Yashtyamalaki churna in study group with Growth Factor Concentration therapy along with internal administration of Yashtyamalaki churna of comparator group.
 
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