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CTRI Number  CTRI/2024/03/063702 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Treatment For Hairfall and Hair loss 
Scientific Title of Study   An Open Labelled Clinical Study to Know The Efficacy Of Growth Factor Concentrate Therapy With Keshya Taila In Khalithya (Male Pattern Baldness) 
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 Raju S N 
Designation  PhD Scholar  
Affiliation  J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital 
Address  Room no 135 ,Ground floor, Department of Shalakya Tantra J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital college road Nadiad

Kheda
GUJARAT
387001
India 
Phone  8150820271  
Fax    
Email  gonchigarraju@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganga R Hadimani 
Designation  Professor and HOD  
Affiliation  J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital 
Address  Room no 135 ,Ground floor, Department of Shalakya Tantra J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital college road Nadiad

Kheda
GUJARAT
387001
India 
Phone  8780067570  
Fax    
Email  gangupatil2001@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raju S N 
Designation  PhD Scholar  
Affiliation  J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital 
Address  Room no 135 ,Ground floor, Department of Shalakya Tantra J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital college road Nadiad

Kheda
GUJARAT
387001
India 
Phone  8150820271  
Fax    
Email  gonchigarraju@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and hospital ,koppal 
 
Primary Sponsor  
Name  Dr Raju S N  
Address  Room no 135 ,Ground floor, Department of Shalakya Tantra J S Ayurveda Mahavidyalay and P D Patel Ayurved Hospital college road Nadiad 
Type of Sponsor  Other [Self] 
 
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 Raju S N   Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital  Department of shalakya tantra ,Room no 42 , Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and HospitalGavimut Campus koppal(T)(D) 583231 karnataka
Koppal
KARNATAKA 
8150820271

gonchigarraju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee for Human Research  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: KESHYA TAILA, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  1.Patients have the classical clinical features of Khalithya.
2. Patients aged between 18 to 40 years.
3. Patients who are having Male pattern Baldness.
4. Norwood Hamilton Scale up to G3 vertex. 
 
ExclusionCriteria 
Details  1. Alopecia totalis, Alopecia aerata, Tinia capitis, Aroomshika
2. Patients suffering from systemic diseases like anemia, cancer, diabetic mellitus, rheumatological disorders, SLE, Hypertension,
3. 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.
4. Norwood Hamilton Scale from G5-G8.
5. Local infection at sight of procedure,
6. Hb-less than 10g/dl, platelet count less than 105000/ml.
7. Tobacco and alcohol use. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The expected outcome of the study is to assess the reduction in hair fall, and increase in the hair growth  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
complete reduce in the hairfall   5 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/03/2024 
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="6"
Days="0" 
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  
One’s personality and general identity are both reflected in their hair. In women, hair is femininity and adornment provided by nature. A full head is often associated with youth and vitality in men. It serves as the pinnacle of one’s personality and serves as the center of attention. As a result, everyone is more aware of the issue and looking for better hair growth treatment. Everyone is aware of the growing social problems of hair loss, pattern baldness, hair thinning, and other related difficulties, but many choose not to discuss them. Consequently, all genders have strong feelings about hair. Pollution, poor food and exercise habits, stress and tension, increased industrialization, and urbanization, as well as other inherent environmental and hereditary causes, all contribute to the rising rate of obesity in today’s fast-paced society. Any type of hair loss can affect one’s physical appearance and psychological well-being.
In Ayurveda, hair loss problem has been described as khalitya. Acharya Vagabhatta has described khalitya under the heading of Shiro-Kapalagata rogas.Acharya Vagabhatta differentiated Indralupta and Khalati by saying that in Khalati loss of hair occurs gradually than Indralupta, while pathology is common in both the diseases of hair. Acharya Charaka describes that Tejas combining with Vata adi dosha reaches the Shira kapala and causes hair fall by dahana of Romakupa Acharya Sushruta also mentioned the same Nidana and Samprapti as Charaka but under Kshudra roga.5 In present era life is very fast & competitive. So, people take junk foods miscombination of food i.e Abhishyandhi & Akalabhojana, over eating i.e Adhyashana, spicy and oily food i.e ushna, Tikshna Ahara etc. Khalithya can be categorized as Male pattern baldness. Androgenetic alopecia is a generic form of hair loss in both men and women. In men, it is also known as male pattern baldness, and in women, it is also known as female pattern hair loss. In
men, hair is lost in a well-defined pattern, beginning above both temples. Over time, the hairline moves back (recedes) to form a characteristic "M" shape. (“Androgenetic alopecia: MedlinePlus Genetics”) Hair also thins at the top of the head (vertex or crown), often progressing to partial or complete baldness. The pattern of hair loss in women differs from male-pattern baldness. In women, the hair becomes thinner at the top of the head, and the middle part widens. The hairline does not typically recede. Androgenetic alopecia in women rarely leads to total baldness. Androgenetic alopecia in men has been associated with several other medical conditions, including coronary heart disease and enlargement of the prostate. Additionally, prostate cancer, disorders of insulin resistance (such as diabetes and obesity), and high blood pressure (hypertension) have been related to androgenetic alopecia. 2 In women, this form of hair loss is associated with an increased risk of polycystic ovary syndrome (PCOS). Alopecia areata is an immune-mediated condition leading to non-scarring alopecia of the scalp and other hair-bearing areas of the body. It affects up to 2% of the global population. It can affect all ages, but the prevalence appears higher in children compared to adults (1.92%, 1.47%). A greater incidence has been reported in females than males, especially in patients with late-onset disease, defined as age greater than 50 years.3 PCOS is characterized by a hormonal imbalance that can lead to irregular menstruation, acne, excess hair elsewhere on the body (hirsutism), and weight gain. Ayurveda claims that vitiated pitta and vitiated vata work together to induce hair loss from the scalp. The orifices of the hair follicles are then blocked by vitiated Rakta and kapha, which inhibits the formation of new hair. Thus, the key internal causal components of khalithya are Rakta dushya (one of the areas in the body where the disease arises) and the vata, pitta, and kapha dosha (three factors responsible for all physiological processes inside the body. There are currently many treatment modalities are available in modern medicine: surgical
restoration and non-surgical restoration of hair like Intralesional corticosteroids, topical corticosteroids, minoxidil, anthralin, topical immunotherapy, prostaglandin analogues, topical retinoids, bexarotene 3 among all even though there is marked improvement from current treatments for this illness, but these are not fully curative or preventative. The new treatment modalities like PRP (platelet rich plasma) therapy and GFC (growth factor concentrate) are having marked improvement when it is done with other supporting oral medications like finasteride, biotin supplement. But after stopping the oral medications and topical solutions again the patient will see the hair fall and thinning so it has become dependent therapy so to overcome that There is a need for treatment that eases hair growth. Plasma has various Growth factors which are stored in blood platelets, which help regenerate and repair the tissues and stem cell proliferation, migration, and differentiation. As each growth factor plays a different role in the regrowth of the hair follicle like Platelet-derived Growth Factor (PDGF): PDGF helps increase hair growth and works as a stimulator for Vascularization and Angiogenesis. It also helps in the mitogenesis of mesenchymal stem cells and endothelial cells and proliferation and chemotaxis of fibroblasts. Vascular Endothelial Growth Factor (VEGF): VEGF is expressed in DP cells in the anagen phase of hair and regulates perifollicular angiogenesis in hair. It also increases perifollicular vessel size during the anagen growth phase to make the process smooth. Epidermal Growth Factor (EGF): EGF promotes hair cell proliferation and regeneration and stimulates mitogenesis of mesenchymal and epithelial cells. Additionally, it also co- stimulates angiogenesis. Insulin-like Growth Factor-1 (IGF-1): IGF-1 keeps HF growth, increases overall hair growth, and works as an angiogenesis stimulator.5 Hence the integrated approach by selecting GFC therapy in addition with ayurvedic Shamanoushadhis we can treat the cases of khalithya effectively. The drugs selected in the study are the drugs which are quoted in Bhavaprakasha6 as keshya these selected drugs will be used to prepare a Kesha Taila and orally.
 
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