| CTRI Number |
CTRI/2024/10/075835 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on the Management of Hair fall |
|
Scientific Title of Study
|
A Study on Clinical Efficacy of Amalaka Rasayana (Internal) And
Pratimarsha Nasya with Chandanadi Taila in the Management of Khalitya |
| 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 G Srividya |
| Designation |
Post graduate in KayaChikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic Medical college & Hospital |
| Address |
Ft no 141, satyarajya laxmi appartments,kalyan nagar, east anand bagh, malkajgiri
Room no 2, unit 2, Dr BRKR Govt Ayurvedic Medical College and Hospital. Erragadda,Hyderabad, 500018
Hyderabad
TELANGANA
500047
India |
| Phone |
9492371963 |
| Fax |
|
| Email |
drvidya1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Laxmikantham |
| Designation |
Professor, MD Ayurveda, Department of Kaya Chikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic college & Hospital |
| Address |
Room no -2 Kayachikitsa OPD, DR. BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Laxmikantham |
| Designation |
Professor, MD Ayurveda, Department of Kaya Chikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic college & Hospital |
| Address |
Room no -2 Kayachikitsa OPD, DR. BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad, 500018, Telangana, India
|
|
|
Primary Sponsor
|
| Name |
Dr G Srividya |
| Address |
Ft no 141, satyarajya laxmi appartments,kalyan nagar, east anand bagh, malkajgiri,500047 |
| 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 G Srividya |
Dr BRKR Govt Ayurvedic Medical College and Hospital |
Department of KayaChikitsa, Room no 2, Erragadda, 500018, Hyderabad, Telangana
Hyderabad
TELANGANA |
09492371963
drvidya1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Of Dr. BRKR Government Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 | Drug | Classical | | (1) Medicine Name: Amalaka Rasayanam, Reference: Astanga Hridaya uttara sthana 39th chapter, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: chakradatta chapter 55 verses 108-110, Procedure details: 2 drops in each nostril every morning for 90 days )
(1) Medicine Name: Chandanadi taila, Reference: chakradatta chap 55, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient complaining of hair fall
2. Patient with age between 18 to 40 years irrespective of gender
3. Patients who are indicated for Nasya karma
4. Patients who are willing to participate in the study and who sign the consent form |
|
| ExclusionCriteria |
| Details |
1.Patients with systemic disorders
2.Patients underwent for chemotherapy
3.Pregnant women and lactating mothers
4.Patients with alopecia areata and alopecia totalis
5.Patients suffering with scalp psoriasis
6.Patients who are contraindicated for Nasya karma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Hairfall |
90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve Hair thickness and strength |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvidya1010@gmail.com].
- For how long will this data be available start date provided 04-11-2024 and end date provided 04-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hair is an epidermal appendage, a defining feature of mammals. Not only does it enhance beauty
and personality, but it also serves critical functions such as thermoregulation, physical protection,
and sensory activity. Healthy, appealing hair contributes to mental enthusiasm and overall, wellbeing. While it’s normal to shed 50 to 100 hair strands daily, new growth usually replaces them.
However, this balance can be disrupted by various factors, including genetic predisposition, stress,
environmental pollutants, malnutrition, and more. In Ayurveda, hair loss is termed "Khalitya." When Vitiated Pitta and Vata affect the hair follicles
(Roma kupa), hair loss occurs. Subsequently, Kapha and Rakta obstruct these follicles, hindering
hair regeneration. Ayurveda identifies several contributing factors, including dietary imbalances, Ati
usna ahara, Ati lavana sevana, Ati kshara sevana and Virudha ahara sevana (incompatible foods),
Atapasevana (prolonged sun exposure), Krimi and the presence of Ama (toxins). Conditions like
Dharunaka (dandruff) and Arumshika (pustules) also contribute to hair loss.
Modern medicine refers to hair loss as alopecia or baldness, which can be partial or complete.
Conventional treatments include hormone replacement therapy, cosmetic transplant surgery, drugs
like minoxidil, and PRP therapy, but they often have limited success. In contrast, Ayurveda offers a
wide array of treatments, including Nasya (nasal therapy), Raktamoksana (bloodletting), Lepas
(herbal pastes), and Dhara (herbal oil treatment), along with various Rasayanas (rejuvenative
therapies). Typically, hair loss tends to increase after the mid-forties as a part of geriatric physiological changes.
However, if it occurs before this age, it can be indicative of premature aging, and Ayurvedic
Rasayanas can be employed to address this condition effectively. |