CTRI Number |
CTRI/2021/07/035015 [Registered on: 20/07/2021] Trial Registered Prospectively |
Last Modified On: |
12/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Nasya] |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Nasya Therapy in Premature Graying of Hair |
Scientific Title of Study
|
Study to evaluate the efficacy of Vibhitaka Majja Taila Nasya in Premature Graying of Hair (Akaala Palitya) |
Trial Acronym |
pavan |
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Reshma Shekh |
Designation |
MD Scholar, Swasthavritta Department |
Affiliation |
Pt. Khushilal Sharma Govt. Ayurveda College, Bhopal |
Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute
Science Hills Behind MANIT
Bhopal
Bhopal MADHYA PRADESH 462003 India |
Phone |
|
Fax |
|
Email |
reshmashekh93@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Reshma Shekh |
Designation |
MD Scholar, Swasthavritta Department |
Affiliation |
Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal |
Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute
Science Hills Behind MANIT
Bhopal
Bhopal MADHYA PRADESH 462003 India |
Phone |
|
Fax |
|
Email |
reshmashekh93@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Reshma Shekh |
Designation |
MD Scholar, Swasthavritta Department |
Affiliation |
Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal |
Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute
Science Hills Behind MANIT
Bhopal
Bhopal MADHYA PRADESH 462003 India |
Phone |
|
Fax |
|
Email |
reshmashekh93@gmail.com |
|
Source of Monetary or Material Support
|
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute |
|
Primary Sponsor
|
Name |
Pt Khushilal Sharma Govt Autonomous Ayurveda College Institute |
Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute |
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 Nitin Marwaha |
Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal |
OPD No 8, Department of Swasthavritta,
Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal Bhopal MADHYA PRADESH |
9425377177
marwahaayu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal (M.P) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E538||Deficiency of other specified B group vitamins. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Normal Saline Water Nasya |
2-2 drops of Normal Saline Water Nasya twice a day preferably in morning and evening time |
Intervention |
Vibhitaka Majja Taila Nasya [Pratimarsha Nasya] |
2-2 drops of Vibhitaka Majja Taila Nasya [Pratimarsha Nasya] twice in a day preferably in morning and evening time |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Both |
Details |
Patients who has not used hair dye / mehndi for last 6 months.
Patients who are willing to sign the written consent form. |
|
ExclusionCriteria |
Details |
Patients with age below 15 years and, above 25 years.
Patients with pernicious anemia and any other autoimmune disease.
Known cases of hormonal , hepatic and renal disorder.
Patients on chemotherapy.
Patients using dyes and mehndi regularly.
Pregnant and Lactating women. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
20% of grey hair changes to natural color |
1 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Marked improvement in grey hairs |
3 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
26/07/2021 |
Date of Study Completion (India) |
31/07/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
24/02/2022 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ø In present study Randomly selected 40 patients of Akaal Palitya
were allocated into two group (20 patients in each group).As group A (
Experimental ) and (Group B) . Total duration of study was 90 days.
Ø In A Group, Vibhitaka majja taila nasya had
administer 2-2 Drops of each nostril [Pratimarsha Nasya] twice a
day preferably in the morning and evening time. In group B,
Normal saline water had administered in the dose of 2-2 drop of each
nostril twice a day preferably in the morning and evening time.
Ø Out of registered 40 patients of Akaal Palitya all 40
patients completed the study.
Ø In Group “A†(20 patients) who were treated with Vibhitaka Majja Taila
Nasya had shown significant improvement in all subjective parameters
(clinical symptoms) like colour of Hair,dry spllited hair,burning on scalp and objective
parameters like GSS score, Serum Ferritine.
Ø In Group “B†patients (20 patients) who were advised Normal saline
water nasya have shown the insignificant improvement in all subjective
parameters as well as objective
parameters.
Ø On inter group comparison,
Group A patients had shown the better improvement than Group B in all
subjective and objective parameters.
Ø The overall effect, in Group A, 1 (5%) patients showed
moderate improvement while (10%) shows mild improvement, 17(85%) patients
showed unchanged
Ø result, whereas none(0%)of patients showed marked improvement.
Ø In Group B, 1(5%) patients showed mild improvement, 19 (90%)
patients showed unchanged result and none (0%) of patients showed moderate
improvement and marked improvement.
Ø From the above observation it is obvious that Vibhitaka Majja
Taila Nasya provided better relief in all parameters as compare to Group B. |