| CTRI Number |
CTRI/2024/07/070715 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| 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
|
To Compare and See the effect of two species of ayurvedic herb sariva in the management of Mukhdushika (Acne Vulgaris) |
|
Scientific Title of Study
|
A Clinical Study To Compare Shweta Sariva-Hemidesmus Indicus (Linn.) R. Br.
And Krishna Sariva- Cryptolepis Buchanani Roem & Schult In The Management
Of Mukhdushika (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 |
Kajal Dabas |
| Designation |
MD Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD NO 58 Department of Dravyaguna Institute for Ayurved Studies and research Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8901120147 |
| Fax |
|
| Email |
kajaldabas45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravinder Arora |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room No 30 Department Of Dravyaguna Vigyana
Institute for Ayurved Studies AND Research and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8901309502 |
| Fax |
|
| Email |
docarora26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAJAL DABAS |
| Designation |
MD Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD NO 58 Department of Dravyaguna Vigyana,Institute for
Ayurved studies and research
Kurukshetra
HARYANA
136118
India |
| Phone |
8901120147 |
| Fax |
|
| Email |
kajaldabas45@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kajal Dabas |
| Address |
OPD NO 58 Department of dravya guna vigyana
Institue for ayurved studies and and research Kurukshetra |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Kajal Dabas |
Institute For Ayurved Studies and Research Sec 8 Umri road Kurukshetra |
OPD NO 58 Department of Dravyaguna Institute For Ayurved Studies and Research Sec 8 Umri road Kurukshetra
Kurukshetra
HARYANA |
8901120147
kajaldabas45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: HEMIDESMUS INDICUS, Reference: BHAVPRAKASH NIGHANTU GUDUCHYADI VARGA VERSE238, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: HEMIDESMUS INDICUS, Reference: BHAVPRAKASH NIGHANTU GUDUCHYADI VARGA VERSE238, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: CRYPTOLEPIS BUCHANANI, Reference: BHAVPRAKASH NIGHANTU GUDUCHYADI VARGA VERSE238, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: CRYPTOLEPIS BUCHANANI, Reference: BHAVPRAKASH NIGHANTU GUDUCHYADI VARGA VERSE238, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary males/females with sign and symptoms of Mukhdushika .
2. Patients from age group of 15-40 years will be selected.
3. No treatment of acne in past 10 days.
4. All skin types (greasy, normal) except sensitive skin.
5. Accepting not to use products with the same end benefits during the entire study duration.
6. Having signed a Consent Form and will be once informed orally and in writing of all information
concerning the study procedures and study objectives. |
|
| ExclusionCriteria |
| Details |
1. Patients having dermatological or any other medical problem such as folliculitis and boils or history
of allergic dermatitis.
2. Patients using any topical retinoid, topical and systemic steroids, throughout the duration of the
study.
3. Patients who are known cases of immune-compromised disease, uncontrolled diabetes, any
systemic illness which may interfere with study treatment and procedure.
4. Patients who are known cases of any malignancy.
5. Pregnant and lactating women and patients who are known cases of PCOD or any other
gynaecological problems.
6. Any known hypersensitivity to any cosmetic and raw material.
7. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial |
|
|
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 |
-Efficacy will be checked through the GAGS score and subjective criteria after
treatment period of 30 days.
|
GAGS Score reduced during 30 days of treatment period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relapsing of the disease will be assessed in the follow up period that is 45th and
60th day of our trial.
-Changes in affected area will also be assessed. |
Follow up at 45th & 60th day of trial |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The skin, our largest organ, serves as a crucial barrier against external factors, including pollutants and microbes. Acne vulgaris (Mukhdushika), prevalent among teenagers and adults, affects quality of life significantly. Ayurveda attributes it to vata, kapha, and rakta dosha imbalances, treatable traditionally with vamana and lepana therapies. Modern medicine focuses on pilo-sebaceous unit inflammation and sebum overproduction due to hormonal, bacterial, and allergic triggers. Hemidesmus indicus (Sweta sariva) traditionally aids skin disorders by cooling and detoxifying raktadhatu. However, its overharvesting threatens extinction, prompting exploration of Cryptolepis buchanani (Krishna sariva) as an alternative. This study compares their efficacy in churna and lepa formulations for acne treatment. Cryptolepis buchanani, richly available, may substitute Hemidesmus indicus, enabling sustainable therapeutic practices. This research aims to generate clinical evidence supporting its effectiveness, steering future acne treatments. |