| CTRI Number |
CTRI/2024/09/073218 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the effect of amrit bhallatak intervention on hairfall patients |
|
Scientific Title of Study
|
A clinical study to evaluate keshya effect of amritbhallatak w.s.r. to hairfall |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Tiwari |
| Designation |
Pg scholar |
| Affiliation |
National institute of ayurveda |
| Address |
National institute of ayurveda, jaipur
First floor dravyagun department room no.137
Jaipur
RAJASTHAN
302001
India |
| Phone |
8005793141 |
| Fax |
|
| Email |
priyatiwari306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National institute of ayurveda |
| Address |
National institute of ayurveda, jaipur
First floor Dravyagun department room no.137
Jaipur
RAJASTHAN
302001
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Tiwari |
| Designation |
Pg scholar |
| Affiliation |
National institute of ayurveda |
| Address |
Department of dravyagun room no. 137 national institute of ayurveda, jaipur
Jaipur
RAJASTHAN
302001
India |
| Phone |
8005793141 |
| Fax |
|
| Email |
priyatiwari306@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of ayurveda , jaipur jorawar Singh gate India.Pin code :302002 |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
Department of dravyagun national institute of ayurveda jorawar Singh gate, jaipur India pin code:302002 |
| 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 Priya Tiwari |
NATIONAL INSTITUTE OF AYURVEDA |
Room no.137 dravyagun department
Jaipur
RAJASTHAN |
8005793141
priyatiwari306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National institute of ayurveda |
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: Amrit bhallatak , Reference: Chakradatta chapter 66 shlok 196, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients withthe classical features of Hair fall since one month or more, resulting in reduced density. |
|
| ExclusionCriteria |
| Details |
1. Patients who have disease like Indralupta (Alopecia totalis), Tinea capitis, hair fall due to chemotherapy.
2.Patients with pitta dominance.
3.Females with menorrhagia, pregnancy and lactating mothers.
4.Summer season (Grishma ritu), Sharad ritu. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome–The changes in hair fall after two months of therapy |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hair quality,its color, strength, thickness and lustre |
8 weeks |
|
|
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)
|
01/11/2024 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
Kesh patan is primarily tridosh janya vyadhi. Vitiated pitta along with vitiated vata leads to weakening or withering of hair from the hair roots. Vitiated kapha along with rakta obstruct the hair roots (romkoop) which prevent further growth of hairs. As perAyurveda, Kesha -hair is the byproduct (Mala) of bone tissue (Asthi dhatu).Hence, nourishment of bone tissue gives rise to good hair growth. For the purpose of good bone tissue nourishment, overall nourishment of other tissues is necessary. Amritbhallatak is considered an effective rasayana. It gives thick black hairs, piercing eyes, delicacy, force, strength, voice, digestion, charm, virility, health and 200 years of longevity. |