| CTRI Number |
CTRI/2022/06/043072 [Registered on: 07/06/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Skin disease] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study effect of sarivadi him, vachadi lepa and triphla churan in Yuvan Pidika(Acne Vulgaris). |
|
Scientific Title of Study
|
To Study Srotas and Dhatu Dusti in Aetiopathogenesis of Yuvan Pidika(Acne Vulgaris) With its Siddhantic chikitsa(principle management). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr satish gandharve |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi govt. Post graduate ayurvedic college and hospital, paprola |
| Address |
Room no 404 Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418143549 |
| Fax |
|
| Email |
satishgandharve@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr satish gandharve |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi govt. Post graduate ayurvedic college and hospital, paprola |
| Address |
Room no 404 Rajiv Gandhi Govt. Post Graduate Ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418143549 |
| Fax |
|
| Email |
satishgandharve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita parihar |
| Designation |
Pg scholar |
| Affiliation |
Rajiv Gandhi govt. Post graduate ayurvedic college and hospital, paprola |
| Address |
Room no.405 Rajiv Gandhi Govt. Post Graduate Ayurvedic college and hospital, Paprola
Room no.407 Rajiv Gandhi Govt. Post Graduate Ayurvedic college and hospital, Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9627600099 |
| Fax |
|
| Email |
drankitaparihar@protonmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Charak pharmacy RGGPG Ayurvedic college and hospital paprola |
| Address |
Rajiv Gandhi ayurvedic college and hospital paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Deptt of samhita and siddanta RGGPG Ayurvedic college and hospital paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr satish gandharve |
Rajiv Gandhi ayurvedic college and hospital, paprola |
Room no. 404 RGGPG Ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH |
7018241280
satishgandharve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human) RGGPG Ayurvedic college and hospital paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: KSHUDRA ROGAH, (2) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarivadi him, Reference: Sidh yog sangreh, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphla churan, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vachadi lepa, Reference: Sushrut samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients willing for trial.
b) Patients 14-35 yrs of either sex.
c) Patients with classical sign and symptoms of Yuvan pedika:
i. Shalmali kantaka prakhya pidika (the eruption seems to be pointed and
conical)
ii. Saruja (Painful eruption)
iii. Ghana (eruption are close
together.)
iv. Medogarbha (the eruptions on extraction emit a thick, oily and whitish discharge)
v. Shoth (Inflammation) |
|
| ExclusionCriteria |
| Details |
a) Patients not willing for trial or not ready to give informed consent.
b) Patients whose age is less than 14yrs and above 35yrs.
c) Patients having any local secondary infection ie. Folliculitis, impetigo, abcess.
d) Patient suffering from any diseased condition such as anal fissure,fistula-in-ano, anal prolapse and piles.
e) Failure of patients to follow up successive visits. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms relief which will be shown by patients in signs and symptoms. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in painfull eruptions and decrease in inflammation which will be shown by patients in signs and symptoms. |
15days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skin diseases are common and troublesome nowadays and one of such disease is Yuvan Pidika which comes under kshudra rogas in different classical Ayurvedic text.It is named so because it is not a serious or life threatening disorder but it has cosmetic effects in the life of a person. This study has been planned: To evaluate the efficacy of "Sarivadi Him", "Vachaadi lepa" And triphala churan in Yuvan Pidika |