| CTRI Number |
CTRI/2023/07/055472 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of akala palitya by using Japapushpa ras nasya. |
|
Scientific Title of Study
|
A single armed clinical study to evaluate effectiveness of Japapushpa ras nasya in Akala palitya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Ashok Kumar Shukla |
| Designation |
MD Scholar |
| Affiliation |
Dr.G.D.Pol foundation, Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
| Address |
Panchkarma department.Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8689930775 |
| Fax |
|
| Email |
aakshishukla4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Ashok Kumar Shukla |
| Designation |
MD Scholar |
| Affiliation |
Dr.G.D.Pol foundation, Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
| Address |
Panchkarma department.Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8689930775 |
| Fax |
|
| Email |
aakshishukla4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Virendranath Jagdish Tiwari |
| Designation |
Professor |
| Affiliation |
Dr.G.D.Pol foundation, Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
| Address |
Panchkarma department.Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9821642085 |
| Fax |
|
| Email |
virendra.tiwari001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
|
|
Primary Sponsor
|
| Name |
Shruti Ashok Kumar Shukla |
| Address |
Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
| 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 |
| Shruti Ashok Kumar Shukla |
Dr.G.D.Pol foundation, Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar |
Panchkarma Department.Dr.G.D.Pol foundation,
Y.M.T Ayurvedic College and Hospital,Institutional area,Kharghar
Raigarh
MAHARASHTRA |
8689930775
aakshishukla4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee YMT ayurvedic college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L679||Hair color and hair shaft abnormality, unspecified. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sushrut Chikitsa sthana 40/21, Procedure details: Purvakarma:
Sambhar Sangrah
Rogi pariksha- it includes selection of patient, selection of drugs and duration
The nasal therapy will be administered after all the urges were voided.
1. Sthanik Abhyanga – patient will be asked to lie in supine position and sthanik abhyanga
will be done with tila taila
2. Mridu Nadi sweda (dashmool kwatha) for head will be done at a safe distance
3. A cloth should be placed covering the head & eyes before giving nadi sweda to protect
the eyes.
Pradhana k)
(1) Medicine Name: Japapushpa Ras, Reference: Rasa Ratnakar (rasayan khand 5/37), Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 1(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are indicated for nasyakarma.
2.Patient who are willing to participate in the study.
3.Patient of either sex aged 18 - 30 yr.
4.Patient having features of Akala Palitya
|
|
| ExclusionCriteria |
| Details |
1.Patient with infectious disease of scalp like ALOPECIA AREATA,
Akala Palitya associated with other diseases of pigmentation like Vitiligo, Leprosy and Albinism.
2. If dyed hair
3.K/C/O- Pernicious Anaemia, Hormonal Disease, Hereditary Disorder or lactating mother, Female planning to conceive or any systemic disorder.
4.Nasya Ayogya.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of grey hair count after 7 days of Japapushpa ras nasya
|
14 and 90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Same as primary
|
14 & 90th day |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
30/07/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM To Evaluate the efficacy of JAPAPUSHPA RAS nasya in AKALA PALITYA.OBJECTIVE To Evaluate the Efficacy of JAPAPUSHPA RAS NASYA IN reduction OF PALITYA. CRITERIA OBJECTIVE PARAMETER According to GSS(greying severity score) Scalp will be divide into 5 zones and will be evaluated by 2 independent investigators. Each of these zones, with maximum grey hair will be identified on visual examination 1 cm2 area will be marked with skin marker and image will be taken and projected on screen to count number of white and black hair. Based on the hair count, a score will be assigned to each zone according to the percentage of gray hair in each square. This will be calculated and scored as: Score 1 (assigned to under 10% gray hair/cm2); Score 2 (10%– 30% gray hair/cm2); and Score3 (more than 30% grey hair/cm2). Then sum of the scores at 5 representative sites will be done. Gradations: Marked improvement more than 75% reduction in GSS score Moderate improvement >50% to 75% reduction in GSS score Mild improvement 50% reduction in GSS score Sample Size- 43 Treatment details: Treatment: Will be treated with Japapushpa avapeed nasya Nasya Matra: 1 karsha Nasya kaal: Pratakal (morning) Duration of treatment: 7 days. Follow up: After the treatment of nasya on 14th day and 90th day. Diet: Patients regular diet: Pathya- Apathya advised to patients. NAME OF STUDENT- DR SHRUTI ASHOK KUMAR SHUKLA NAME OF GUIDE- DR VIRENDRANATH TIWARI STUDY CENTRE-DR G.D.POL FOUNDATION YMT AYURVEDIC COLLEGE AND HOSPITAL KHARGHAR NAVI MUMBAI
|