| CTRI Number |
CTRI/2024/07/070764 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effects of Medicated Oil in the management of Hairloss |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial of
Gunjadi Tail and Malatyadi Tail along With Patoladi
Kwath in Khalitya W.S.R. TO Pitta Dosha
|
| 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 Chhote Khan |
| Designation |
MD scholar |
| Affiliation |
national institute of ayurveda jaipur |
| Address |
Department of Kriya Sharir
National Institute of Ayurveda
Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7733911494 |
| Fax |
|
| Email |
ckhan0321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendar Prasad |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of kriya Sharir
National institute of ayurveda
Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Prakash Gurao |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of kriya Sharir
National Institute of Ayurveda
Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9970935750 |
| Fax |
|
| Email |
drrashmigurao@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh gate Amer road Jaipur302002 Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Near Jorawar singh gate, Amer road jaipur 302002 Rajasthan |
| 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 Chhote Khan |
National Institute of Ayurveda Jaipur |
OPD NO 3, dept of kriya sharir, National Institute of Ayurveda, Deemed to be University
Jorawar Singh Gate, Amer Road, Jaipur (Raj.) - 302002
Jaipur
RAJASTHAN |
7733911494
ckhan0321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Malatyadi Tail , Reference: (à¤à¥ˆà¤·à¤œà¥à¤¯ रतà¥à¤¨à¤¾à¤µà¤²à¥€ 60/140), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Local application at hair root. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gunjadi Tail , Reference: (चकà¥à¤°à¤¦à¤¤ 55/90), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -Local application at hair root. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having Hair fall.
2. Subjects between 20-45 years age group.
3. Either Sex.
4. Anemic subjects with hair fall
|
|
| ExclusionCriteria |
| Details |
1. Known case of genetic disorder, radiotherapy, chemotherapy after pregnancy, dandruff, bacterial, virus and fungal infection, etc.
2. Known case of Alopecia totalis and Alopecia universalis patients will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome – Changes in assessment parameters like Hair Fall on washing, Combing
and Hair Pull tug test.
|
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome – Changes in serum ferritin and Total Iron binding capacity. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Need of Study- Hair fall is a universal problem, having affected both sexes of all races to different extents for as long as mankind has existed. For thousands of years, men and women of all countries and races have shared the tragedy of premature hair loss. Throughout history and in most civilizations, scalp hair has been associated with positive signals such as beauty and power. Genetic predisposition and hormonal factors predominantly contribute to hair fall. Apart from hormonal factors, other reasons for hair loss in both sexes can be stress and improper nutrition. Oil is also one of the modalities of treatment commonly prescribed in the management of Khalitya. Gunjaadi Tail and Malatyadi Tail are indicated in the treatment of Khalitya by Chakradatta.Management of hair fall is extremely complex. Although no sweeping cure exists for hair loss, several treatments are available to depending on their unique reasons for experiencing hair loss. Hormone therapy uses of reeducates inhibitors, and vasodilators like minoxidil are widely used to reduce hair fall / loss. The use of some of the herbal oils is also reported to reduce the hair fall/loss. This study is intended to compare the effect of Gunjadi tail and Malatyadi tail in Khalitya. Research Question – Is there any difference in the Gunjadi tail and Malatnadi tail in Khalitya? Research Gap-There is lots of work done on the treatment modalities for Hair fall in Contemporary and Ayurveda Science. But still there is no any proper modalities give satisfactory result in above mentioned problem. Keeping above points in mind study will design. Aim – To compare the effect of Gunjadi tail and Malytadi tail in Khalitya. Objective – 1) Assessment of Pitta dosha involved in the pathology of Khalitya. 2) To evaluate the efficacy of Gunjadi tail in Khalitya 3) To evaluate the efficacy of Malatyadi tail in Khalitya Statement of Hypothesis – Null Hypothesis – There is no difference in the effect of Gunjadi tail and Malatyadi tail in Khalitya. Alternate Hypothesis – There is difference in the effect of Gunjadi tail and Malatyadi tail in Khalitya. |