| CTRI Number |
CTRI/2023/06/054469 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of Divyaratan oil in patients with Headache, Mental Tension and Fatigue. |
|
Scientific Title of Study
|
A Prospective, Single arm, Open label, Single centre clinical study to evaluate the safety and efficacy of Divyaratan oil in reducing headache, mental tension and fatigue. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2305 Version 1.0 dated 17 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Dr Udays Advance Skin and Hair Clinic |
| Address |
Dr. Uday’s Advance Skin and Hair clinic #2637/6, First floor, Begur Rd, Near Canara bank, Begur, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
6364147989 |
| Fax |
|
| Email |
info@samahitha.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Vijay Kimtata |
| Designation |
Research Technical |
| Affiliation |
Aryanveda Cosmoceuticals |
| Address |
Aryanveda Cosmoceuticals 128, Nalagarh Bhartgarh road, VPO Rajpura, Near GPI textile Pvt Ltd, Tehsil Nalagarh, Dist.Solan, Himachal Pradesh
Solan
HIMACHAL PRADESH
174101
India |
| Phone |
9816333352 |
| Fax |
|
| Email |
vijaykimtata.vk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunita C |
| Designation |
Team Lead |
| Affiliation |
Samahitha Research Solutions |
| Address |
No 1204 ASHVA second floor 26th main road Jayanagar 9th block Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
6364147980 |
| Fax |
|
| Email |
sunita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Aryanveda Cosmeceuticals
128, Nalagarh bhartgarh road, VPO Rajpura,Near GPI textile pvt Ltd, Tehsil Nalagarh, Distt Solan, Himachal Pradesh-174101 |
|
|
Primary Sponsor
|
| Name |
Aryanveda Cosmeceuticals |
| Address |
128, Nalagarh bhartgarh road, VPO Rajpura,Near GPI textile pvt Ltd, Tehsil Nalagarh, Distt Solan, Himachal Pradesh-174101 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Uday Kumar |
Dr. Uday’s Advance Skin and Hair clinic |
#2637/6, First Floor, Begur Rd Near Canara Bank, Begur, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
6364147989
info@samahitha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Headache, mental tension and Fatigue |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Divyaratan Hair Oil , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: , Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 28 Days, Reference: , Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18 to 65 years.
2. Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24
points on the Hamilton Scale for Anxiety).
3. Subjects of female gender or a non-pregnant, non-lactating female, at least six weeks
postpartum. A urine pregnancy test is required for all female subjects unless the subject has
had a hysterectomy or tubal ligation, or is > 2 years postmenopausal.
4. Subjects are willing to follow the procedures as per the study protocol and voluntarily sign
an informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Subjects having addiction to any drug, including alcohol will not be recruited in the trial.
2. Subjects who are using any medication such as anxiolytic, anti-stress medication and
under psychotherapy will not be recruited in the trial.
3. Subjects having a chronic, contagious infectious disease, such as active tuberculosis,
Hepatitis B or C, or HIV.
4. Known hypersensitivity to ingredients used in the Investigational Product.
5. Pregnant and Lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To test the Efficacy of the Divyaratan oil to reduce Headache, Tension, minor insomnia, stress & mental tiredness.
Assessment:
Subjective assessment questionnaire will be provided to the each subject, based on that the outcome will be assessed. |
Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To test the Efficacy of the Divyaratan oil to reduce sun stroke by external cooling.
• To evaluate the Safety of the product.
• Mean change in the in Hamilton Rating Scale for Anxiety from baseline visit to week 4.
Assesment :
Hamilton Rating Scale for Anxiety from baseline visit to week 4 will be performed.
|
Week 4 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/07/2023 |
| Date of Study Completion (India) |
15/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Divyaratan oil in reducing headache, mental tension and fatigue.
Primary Objective • To evaluate the efficacy of the Divyaratan oil in reducing headache ,mental tension ,minor
insomnia ,stress and mental tiredness.
Secondary Objective • To evaluate the efficacy of the Divyaratan oil in reducing sun stroke/ heat stroke by external
cooling. • To evaluate the safety of the the Divyaratan oil. |