| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Growth factor concentrate therapy | present 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. |