| CTRI Number |
CTRI/2024/12/077802 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Adityapakva Guduchi Taila and Bhringaraja Taila on Hair Loss with Reference to Alopecia. |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Effect of Adityapakva Guduchi Taila and Bhringaraja Taila in the Management of Khalitya with Reference to Alopecia. |
| 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 Sadhana Yadav |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit university |
| Address |
Deparment of Kayachikitsa, KSVAMCH,Shobhit university. Adarsh
Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur U.P.
India-247341
Saharanpur
UTTAR PRADESH
247341
India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7906916892 |
| Fax |
1331234500 |
| Email |
drsadhanayadav953@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Yadav |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit university |
| Address |
Deparment of Kayachikitsa, KSVAMCH,Shobhit university. Adarsh
Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur U.P.
India-247341
Saharanpur
UTTAR PRADESH
247341
India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7906916892 |
| Fax |
1331234500 |
| Email |
drsadhanayadav953@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana |
| Designation |
Professor And HOD Dept. Of Kayachikitsa |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit university |
| Address |
Deparment of Kayachikitsa, KSVAMCH,Shobhit university. Adarsh
Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur U.P.
India-247341
Saharanpur
UTTAR PRADESH
247341
India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9348061460 |
| Fax |
1331234500 |
| Email |
bandanadhall1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deparment of Kayachikitsa, KSVAMCH,Shobhit university. Adarsh
Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur U.P.
India-247341
Saharanpur
UTTAR PRADESH
247341
India |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit University |
| Address |
Adarsh Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur,
U.P. India-247341 |
| 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 Sadhana Yadav |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit University |
OPD No-1,Deparment of Kayachikitsa, KSVAMCH,Shobhit university. Adarsh
Institutional Area,Babu Vijendra Marg,Gangoh,Saharanpur U.P.
India-247341
Saharanpur
UTTAR PRADESH
247341
India
Saharanpur
UTTAR PRADESH |
07906916892
1331234500
drsadhanayadav953@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Adityapakva Guduchi TAILA, Reference: Chakradatta Chikitsa Sthan (26/110), Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Any individual aged between 16 to 45 years, irrespective of their background, caste, sex, religion and occupation will be included.
2.Subjects presenting with the features of hair fall, not complete loss of hairs.
3.Duration of chief complaint not more than 1 year. |
|
| ExclusionCriteria |
| Details |
1.Subjects whose age is less than 16 & more than 45 years.
2.Subjects who are diagnosed to have local disease like Alopecia totalis, Tinea capitis, Folliculitis devaculans and in Ayurvedic terms Arunshika.
3.Old age, Heredity, Chronic disease.
4.Subjects suffering from any severe systemic disease will be excluded.
5.Subjects taking chemotherapy and steroid therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Khalitya |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement will be assessed on the basis of relief found in symptoms of disease |
6 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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
|
To study the efficacy of Adityapakva Guduchi Taila and Bhringaraja Taila in the management of Khalitya. This study is a single center,open labelled,randomized,interventional comparing the safety and efficacy of Adityapakva Guduchi Taila will be applied as shiro abhyanga in a dosage of 5ml/day and Bhringaraja Taila will be applied as shiro abhyanga in a dosage of 5ml/day for 18 months in 60 patients with khalitya that will be conducted. |