| CTRI Number |
CTRI/2024/06/068869 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of dashmool taila nasya in akala palitya |
|
Scientific Title of Study
|
A single armed clinical study to evaluate the effectiveness of dashmool taila nasya in akala palitya |
| 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 Nikita Shukla |
| Designation |
MD scholar |
| Affiliation |
Dr GD pol foundation YMT Ayurvedic college and hospital, institutional area kharghar |
| Address |
Panchkarma department,
Dr GD pol foundation ymt ayurvedic College and hospital institutional area Kharghar Raigarh,
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08452037114 |
| Fax |
|
| Email |
nikitashukla1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit chavan |
| Designation |
Associate professor |
| Affiliation |
Dr GD pol foundation YMT Ayurvedic college and hospital, institutional area kharghar |
| Address |
OPD No 1.Panchkarma department,
Dr GD pol foundation ymt ayurvedic College and hospital institutional area Kharghar Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8793263413 |
| Fax |
|
| Email |
vdamitchavan07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit chavan |
| Designation |
Associate professor |
| Affiliation |
Dr GD pol foundation YMT Ayurvedic college and hospital |
| Address |
OPD No 1. Panchkarma department Dr GD pol foundation ymt ayurvedic medical College pg institute Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8793263413 |
| Fax |
|
| Email |
vdamitchavan07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panchkarma department
Dr GD pol Foundation YMT Ayurvedic college and hospital institutional area kharghar Raigarh |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Shukla |
| Address |
Dr G D pol foundation ymt ayurvedic medical College pg institute Kharghar Navi Mumbai |
| 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 Nikita Shukla |
Dr G D pol foundation ymt ayurvedic College and hospital institutional area kharghar Raigarh |
Panchkarma department
Dr GD pol foundation ymt ayurvedic College and hospital
Institutional Kharghar Raigarh 410210
Raigarh
MAHARASHTRA |
08452037114
nikitashukla1999@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 | - | marSaH, मरà¥à¤¶ | (Procedure Reference: Ashtang Hriday Sutrasthan,[27/9-10,28], 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 ka)
(1) Medicine Name: Dashmool taila , Reference: Bhaisajya ratnavali shirorogachikitsaprakaran adhyaya 65 shlok no 84,85 , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
34.00 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 16 to 34 years.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 anemia, 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 Dashmool taila nasya |
14 and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Same as primary |
14 and 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)
|
15/07/2024 |
| 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 Yet Recruiting |
| 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
|
AIM: To evaluate the efficacy of Dashmool Taila Nasya in Akala Palitya.
OBJECTIVE : To evaluate the efficacy of Dashmool Taila Nasya in reduction of Akala Palitya.
CRITERIA:OBJECTIVE PARAMETER
According to GSS (graying severity score)[13]
The entire scalp surface will be divided into 5 zones that is frontal region vertex region temporal region, occipital region with special designed head belt. In each of these zones areas showing maximum greying hair will be identified on visual examination. 1cm2 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 : will be treated with dashmool taila nasya Nasya Matra : 6 Bindu Nasya kaal : Pratakaal ( morning) Duration of treatment:7 days Follow up : after the treatment of nasya on 14 th day and 90 th day . DIET: patient regular diet Pathya -Apathya advised to patients.
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