| CTRI Number |
CTRI/2019/04/018372 [Registered on: 02/04/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trail on combined efficacy of Adityapaka Guduchi Hair oil for Shiroabhyanga(Head massage ) and Yastimadhwadi Hair oil for Nasya(Nasal instillation) in Hairfall (Khalitya). |
|
Scientific Title of Study
|
PHARMACEUTICO-ANALYTICAL AND COMBINED
CLINICAL STUDY OF ADITYAPAKAGUDUCHI TAILA SHIROABHYANGA AND YASTIMADHWADI TAILA NASYA
IN KHALITYA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bankimchandra S J |
| Designation |
PG Scholar ,Department of rasa shastra and Bhaishajya kalpana |
| Affiliation |
BVVS Ayurveda college and hospital Bagalkot |
| Address |
Ward no. 10 Mopagar Galli, Banahatti
BVVS Ayurveda college and hospital Bagalkot
Bagalkot
KARNATAKA
587311
India |
| Phone |
9449921088 |
| Fax |
|
| Email |
bsjambagi26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpavati Policepatil |
| Designation |
Professor, Department of Shalakya Tantra |
| Affiliation |
BVVS Ayurveda college and hospital Bagalkot |
| Address |
BVVS Ayurveda college and hospital Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448261405 |
| Fax |
|
| Email |
ppolicepatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykumar Chavadi |
| Designation |
Associate Professor ,Department of rasa shastra and Bhaishajya kalpana |
| Affiliation |
BVVS Ayurveda college and hospital |
| Address |
BVVS Ayurveda college and hospital Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
7411737765 |
| Fax |
|
| Email |
drvbc052@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF FUNDING AND BVV Sangha BVVS Ayurveda Medical College and Hospital Bagalkot. |
|
|
Primary Sponsor
|
| Name |
Pricipal |
| Address |
BVVS Ayurveda college and Hospital Bagalkot |
| Type of Sponsor |
Private medical college |
|
|
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 Pushpavati Policepatil |
BVVS Ayurveda College and Hospital Bagalkot |
BVVS Campus, near Basaveshwara circle, Bagalkot
Bagalkot
KARNATAKA |
9448261405
bsjambagi26@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE ,BVVS AYURVEDA MEDICAL COLLEGE AND HOSPITAL BAGALKOT. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hairfall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Shiro Abhyanga
2.Nasya |
Drug detail
Adityapakaguduchi Taila:
Ingredients:
I. Kalka Dravya: Vata Praroha and Jatamansi: Each drug ½ part
II. Sneha Dravya: Tila Taila: 4 Part
III. Drava Dravya: Guduchi Swarasa: 16 Part
Yastimadhwadi Taila :
Ingredients:
I. Kalka Dravyas – Yastimadhu, Amalaki, each drug- ½ part.
II. Snehadravya – Moorchita Tilataila -4 parts.
III. Drava Dravya – Godugdha -16 parts.
1. Shiroabhyanga : Quantity Sufficient Adityapakaguduchi Taila is used daily for 7 days.
2. Nasya: 8 drops of Yashthimadhukadhya Taila in each nostril once daily for 7days
2 Courses of Nasya and Shiroabhyanga, each course of 7 days with 15 days rest in between. The procedure of Nasyakarma Shiroabhyanga will be followed as per classics.
|
| Comparator Agent |
NIL ,Single arm study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
General Hair fall ,unexplained hair fall |
|
| ExclusionCriteria |
| Details |
Patchy Alopacea, Alopacea totalis, Chemo induced hairfall |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adityapakaguduchi Taila Shiroabhyanga or Yastimadhwadi taila Nasya combined have significant role in preventing Khalitya.
|
30 Patients will be treated with both Adityapakaguduchi Taila Shiroabhyanga and Yastimadhwadi Taila Nasya for 7days. (2 Sittings with 15 day follow up) assessment by pull test and other assessment criteria like Khalitya, keshabhoomi daha ,kesa tanutva, kesha khandu, kesha khatinyata
in |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adityapakaguduchi Taila Shiroabhyanga or Yastimadhwadi taila Nasya combined have significant role in preventing hair fall and further healthy growth of hairs in future. |
It will be assessed after one month of the treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/04/2019 |
| Date of Study Completion (India) |
12/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/02/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Clinical trail on combined efficacy of Adityapaka Guduchi Hair oil for Shiroabhyanga(Head massage ) and Yastimadhwadi Hair oil for Nasya(Nasal instillation) in Hairfall (Khalitya). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Pharmaceutico analytical and combined clinical study of Aditypakaguduchi Taila shiroabhyanga and Yastimadhwadi Taila nasya in khalitya ,This study includes 2 medicines those are 1) Adityapaka Guduchi Taila, 2) Yastimadhwadi Taila, both are prepared from different pharmaceutical procedure and their pharmaceutical study were recorded and along with that analytical studies were also conducted This study comprise of combined treatment protocol of 2 mode of administration which are 1.Yastimadhwadi Taila Nasya (nasal instillation) and 2. AdityapakaGuduchii Taila Shiro abhyanga (Head massage) as explained in ayurveda classics. Conclusions were drawn on the basis of observations and results of pharmaceutical, analytical and clinical study. · Adityapaka Guduchi Taila was prepared by unique method called Adityapaka Vidhi and Yasthimadhwadi Taila was prepared by Agnipaka Vidhi. Both the Taila Kalpas were prepared as per the classical references. · Analytical parameters of Adityapaka Guduchi Taila has shown significant increase in the acid value and saponification value due to unique method of preparation, where as Yasthimadhwadi Taila has standard parameters. · The clinical study has significant role in the prevention of Khalitya based on the clinical parameters like Khalitya, Keshya Khatinyata, Kesha Tanutwa, Keshabhoomi Daha and Keshabhoomi Khandu |