| CTRI Number |
CTRI/2024/03/064925 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of narsingha churna orally and ankolbeej tailam locally in the management of lalitya with special reference to hair fall. |
|
Scientific Title of Study
|
“Randomized open controlled clinical study of therapeutic effect of Narsinha churna orally and
Ankolbeej tailam externally as shiroabhyanga in the management of khalitya w.s.r. to hair fall in the
age group of 18 to 60 yrs†|
| Trial Acronym |
Yes |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajakta pravin Dhawadkar |
| Designation |
PG Scholar Kaychikitsa |
| Affiliation |
Dayabhai mavaji majithiya Ayurveda mahavidyalay yavatmal |
| Address |
Department of Kaychikitsa OPD no 10 ground floor Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9834738588 |
| Fax |
|
| Email |
ppdhawadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Jamdhade |
| Designation |
HOD and Professor of Kaychikitsa Department |
| Affiliation |
Dayabhai mavaji majithiya Ayurveda mahavidyala yavatmal |
| Address |
Department of Kaychikitsa OPD no 10 ground floor Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822201196 |
| Fax |
|
| Email |
drsubhashjamdhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Jamdhade |
| Designation |
HOD and Professor of Kaychikitsa Department |
| Affiliation |
Dayabhai mavaji majithiya Ayurveda mahavidyala yavatmal |
| Address |
Department of Kaychikitsa OPD no 10 ground floor Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal
MAHARASHTRA
445001
India |
| Phone |
9822201196 |
| Fax |
|
| Email |
drsubhashjamdhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal Maharashtra pincode 445001 India |
|
|
Primary Sponsor
|
| Name |
Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal |
| Address |
Department of Kaychikitsa OPD no 10 ground floor Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal Maharashtra pincode 445001 India |
| 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 Subhash Jamdhade |
Dayabhai mavaji majithiya ayurveda mahavidyalay yavatamal |
Lakshmanrao kalaspurkar Ayurved Rugnalay OPD 10
Department of Kaychikitsa arni road shivaji nagar yavatamal
Yavatmal
MAHARASHTRA |
9822201196
drsubhashjamdhade@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:L738||Other specified follicular disorders. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gambhari churna , Reference: Bhavprakash nighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: -(2) Medicine Name: Bhringraj tailam , Reference: Sharangdhar , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narsinha churna , Reference: Bhaishjya ratnavali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: -(2) Medicine Name: Ankolbeej tailam , Reference: Vaidya manorama , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes with an age group between 18 to 60yrs
Cases with classical sign and symptoms of khalitya were considered
Hair fall keshchyuti
Hair pull test
Patients willing for clinical trial
Patients belonging to any socioeconomic class irrespective of cast religion
occupation
Patient who will fulfill criteria and take regular medicines with Regular follow
up |
|
| ExclusionCriteria |
| Details |
Patients not willing for clinical trial
patients whole age is less than 18 & above 60 yrs
Allergic disorders Tinea capitis scalp psoriasis alopecia Scaring and
Non Scaring
Patient is known case of any autoimmune disorder like thyroid disorder
rheumatoid arthritis
Patient taking carcinogenic medicine
Severe Anaemic |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To facilitate the statistical analysis of the effect of trial scoring system
was adopted Reduction of hairs fall within the normal range and keshotpatti was
counted as a main feature to assess the effect of therapy In present clinical
trial the patient will be assessed based on the signs and symptoms mentioned
described in the Ayurvedic Texts
Subjective Criteria
Keshochyuti hair fall |
0 7th 15th 22nd 29th 36th 45th 60th 75th 90th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hair pull test |
0 7th 15th 22nd 29th 36th 45th 60th 75th 90th days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| 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 - NO
|
|
Brief Summary
|
Hair fall is a progressive disorder in people living in sedentary ways of
life, stress induced hectic schedules along with faulty dietary habits problem of
falling hair is progressively increasing in society which is also affecting quality of
life In ayurveda there is no clear description about the causitive factors
of khalitya except acharya charak and vagbhata who mentioned the factors as
follows – pitta prakruti kshara atisevan lavanrasa atisevan ,ushar bhumi viruddha aharsevan |