CTRI Number |
CTRI/2022/04/042180 [Registered on: 26/04/2022] Trial Registered Prospectively |
Last Modified On: |
03/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Other (Specify) [Local Application Of Ayurvedic Hair oil Shiroabhyanga in the darunaka patients.] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Clinical Study of the Shiroabhyanga (Head Massage) of an ayurvedic Hair oil as compared with coconut oil in Darunaka (Dandruff). |
Scientific Title of Study
|
A Randomized Controlled Clinical Study of the Shiroabhyanga (Head Massage) of an ayurvedic Hair oil as compared with coconut oil in Darunaka (Dandruff). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Indrayani Sunil Shrigiriwar |
Designation |
PG Student |
Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune |
Address |
Department of Swasthavritta OPD No 7
Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune MAHARASHTRA 411018 India |
Phone |
8999288873 |
Fax |
|
Email |
shrigiriwar.indrayani95@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Yogesh B Shinde |
Designation |
Associate Professor |
Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune |
Address |
Department of Swasthavritta OPD No 7
Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune MAHARASHTRA 411018 India |
Phone |
9028383505 |
Fax |
|
Email |
yogesh.ayurved@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Indrayani Sunil Shrigiriwar |
Designation |
PG Student |
Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune |
Address |
Department of Swasthavritta OPD No 7
Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune MAHARASHTRA 411018 India |
Phone |
8999288873 |
Fax |
|
Email |
shrigiriwar.indrayani95@gmail.com |
|
Source of Monetary or Material Support
|
Dr D Y Patil College Of Ayurveda and Research Centre Pimpri Pune |
|
Primary Sponsor
|
Name |
Dr Indrayani Sunil Shrigiriwar |
Address |
Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
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 Indrayani Sunil Shrigiriwar |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
Department Of Swasthavritta OPD No 7 Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA |
8999288873
shrigiriwar.indrayani95@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:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: DARUNAKAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | shiro abhyanga | (Procedure Reference: Charak and Sushrut Samhita, Procedure details: )
| 2 | Intervention Arm | Procedure | - | shiro abhyanga | (Procedure Reference: charak samhita and sushrut samhita, Procedure details: 10 ml of formulated ayurvedic hair oil application on the scalp as a head massage daily for 28 days at night for about 3-5 minutes. ) (1) Medicine Name: Ayurvedic hair oil, Reference: Bhavprakash nighatu book, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 28 Days |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Patients of age between 20 to 50 years.
2. Patients showing symptoms of Darunaka.
3. Patients willing to participate in the study.
|
|
ExclusionCriteria |
Details |
1. Patients with other major Physical illness
viz. IHD, Malignancy etc.
2. People having genetic diseases.
3. Patients not willing to participate in the study.
4.The person suffering from other hair and scalp diseases.
5. Psoriasis of scalp , eczema of the scalp , head injury in which head bath/wash is restricted ,fungal infection ,Ringworm infestation to scalp , patients with severe hairfall like Indralupta .
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
An ayurvedic hair oil shiroabhyanga (head massage) is effective in the management of darunaka. |
Day 0 -14 -28
Day 0
1.Ayurvedic parameters of darunaka based on symptoms
2. Tichoscopic image examination.
3. scalp health study.
Day 14th - first follow up
1.Ayurvedic parameters of darunaka based on symptoms
Day 28 - second and last follow up
1.Ayurvedic parameters of darunaka based on symptoms
2. Tichoscopic image examination.
3. scalp health study |
|
Secondary Outcome
|
Outcome |
TimePoints |
Formulated Ayurvedic Hair Oil Shiroabhyanga is effective in the other conditions like scalp health and hair fall rate and follicular strength |
Day 0-14-28
Day 0
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope.
Day 14th - First follow up
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope.
Day 28th - second and last follow up
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope. |
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/05/2022 |
Date of Study Completion (India) |
19/01/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Primary objective - To study the effectiveness of the ayurvedic hair oil shiroabhyanga (head massage) in the darunaka. Secondary objective - To observe the other healthy changes in the scalp and hair like Hair fall rate (if present)
Ayurvedic hair oil will be prepared from total 10 keshya drugs which were given in the Bhawprakash Nighantu. The base of the oil will be black sesame oil. An oil will be prepared by the ancient ayurvedic technique of oil preparation known as Sneha pak vidhi with its given standard proportion of 1:4:16. Study will be in two groups
Group A- 38 patients - Trial group- Ayurvedic hair oil Local application of formulated ayurvedic hair oil shiroabhyanga(head massage) , daily with 10 ml definate quantity , at night for total 28 days .
Total enrollment number will be 38 + 38 = 76 .
Group B - 38 patients - Control group - coconut oil Local application of parachute coconut hair oil shiroabhyanga (head massage), daily with 10 mi definate quantity , at night for total 28 days.
Follow uo schedule - total two followups with intervals of 14 days.
Duration - 28 days
Observation and Conclusion - will be drawn on the basis of proper statistical methods
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