| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L649||Androgenic alopecia, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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 Geneticsâ€) 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. |