| CTRI Number |
CTRI/2025/07/090216 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of Kalyanak Gutika in the management Tarunyapitika with special reference Acne vulgaris
|
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Kalyanak Gutika in the management of Tarunyapitika with special reference to Acne vulgaris
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shital Dnyanoba Kukade |
| Designation |
PG Scholar |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital, Aurangabad |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8329956470 |
| Fax |
|
| Email |
shitalkukade22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arshadkhan Rasulkhan Pathan |
| Designation |
Associate professor |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital, Aurangabad |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshadkhan Rasulkhan Pathan |
| Designation |
Associate professor |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital, Aurangabad |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9096577523 |
| Fax |
|
| Email |
arshupathan78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Nipani bhalgaon road, Beed Bypass, Chhatrapati Sambhajinagar (Aurangabad) , Maharashtra,431005 |
|
|
Primary Sponsor
|
| Name |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital |
| Address |
Nipani-Bhalgaon, near Videocon comp ltd, Beed Highway, Chhatrapati Sambhajinagar ,(Aurangabad), Maharashtra 431005 |
| 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 |
| DrShital Dnyanoba Kukade |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA |
8329956470
shitalkukade22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalyanak Gutika , Reference: Gadnigrah , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: Ingredients - Haritaki 2 parts, Niyojya draksha 1 part, Gutika will be made. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aragwadha-Amrutadi Vati, Reference: Sahastrayoga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: Ingredients -
Pathya 1 part, Khadir 1 part,
Aragwadha 1 part,
Amruta 1 part |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical sign and symptoms of Tarunyapitika.
Patient selected irrespective of sex, religion.
Patients having lakshanas like Ruja, daha, shotha,kandu, shalmali kantak saman pidka |
|
| ExclusionCriteria |
| Details |
Patient having acne other than face( Shoulder, Neck, Abdomen)etc.
Patient having other type of Kshudrarogas and Kushtharog.
Pitika produce due to any allergy.
Patient suffering from DM, HTN, Autoimmune disorders, HIV, Immunosuppressive drugs and any other major illness.
Endocranial disease excluded.
Pregnant and lactating women will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Kalyanak Gutika in the management of Tarunyapitika with special reference to Acne Vulgaris |
follow-up on
7th ,14th , 21st , 28 th Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Kalyanak Gutika and Aragwadha-Amrutadi Vati in the management of Tarunyapitika with special reference to Acne Vulgaris |
follow-up on
7th ,14th , 21st , 28 th Day
|
|
|
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 1 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Tarunyapitika is identified as Pitta-Rakta dominating tridoshaj disease.In today’s lifestyle dietary habits also has been changed and behavioural patterns, disturbed sleep cycle, work life imbalance, hormonal changes and environmental factors, all these condition leads to vitiation of Dosha and Dhatu leads to skin diseases in adults. Now a days , people are very concerned about their physical appearance so that Tarunyapitika is very common cosmetic problem in young adults.Due to vikrit Dosha and Dhatus, it reflects on the face known as Mukhadushika or Tarunyapitika or Youvanpidaka in Ayurveda and Acne Vulgaris in the modern science in adults.Tarunyapitika ( Mukhadushika ) disease itself suggestive of its nature and occurance in the adults which is Madhyama yuvanavstha that is mostly in between the age of 20–30years. The prevalence of acne vulgaris in this age group varries depending on the factors such as geographic location, gender, ethnicity and environmental factors. In the 20-30 age group specifically, prevalence rates tend to be high. It affects 85% of adolescents. Acne is estimated to affect 9.4% of the world’s population with the highest prevalence in adolescents. Tarunyapitika is one of the Kshudraroga mentioned in different classical texts of Ayurveda. According to Ayurveda, the thick and painful eruptions like Shalmali thorn on the face caused due to combined association of vitiated Kapha, Vata doshas along with Rakta along with impregnation of Meda Dhatu are known as Tarunyapitika. In Gadnigrah there is mention of Kalyanak Gutika used in pitika which contains Haritaki and niyojya draksha which acts as a anuloman and raktapradaka also. Haritaki acts as rasayan for all 7dhatus and also tridoshghna so, it breaks the samprati of all types Tarunyapitika when given internally in the doses of 250mg 2Tabs BD. Kalyanak Gutika taken as trial drug and Aragwadha-Amrutadi as control drug in the management of Tarunyapitika with special reference to Acne Vulgaris. |