| CTRI Number |
CTRI/2025/03/083585 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A Clinical study to study the efficacy of Jatiphaladi lepa and Lodhradi lepa along with Khadirashtak kwatha along with the management of Mukhadushika with special referance to Acne Vulgaris |
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Scientific Title of Study
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A Comparative clinical study to evaluate the clinical efficacy of Jatiphaladi Lepa and Lodhradi Lepa along with Khadirashtak Kwatha in the management of Mukhadushika with Special referance to Acne Vulgaris |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakhi Anant Jadhav |
| Designation |
P G Scholar |
| Affiliation |
R.A Podar Ayu. medical college ,Worli Mumbai 400018 |
| Address |
Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical college,M.A POdar hospital, Worli,Mumbai Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical college,M.A Podar Hospital , Worli,Mumbai Mumbai MAHARASHTRA 400018 India |
| Phone |
8007545422 |
| Fax |
|
| Email |
rajanant651997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dilip Uttamrao Wange |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Govt.(Ayu.)College Worli Mumbai 400018 |
| Address |
OPD No. 18, Kayachikitsa Department,M.A Podar Govt.(Ayu.) hospital,R.A Podar Medical(ayu.) college Worli,Mumbai 400018 Kayachikitsa Department,R.A Podar Govt.(Ayu.)Medical College,M.A Podar Hospital,Worli,Mumbai 400018 Mumbai MAHARASHTRA 400018 India |
| Phone |
9892323677 |
| Fax |
|
| Email |
drdilip.wange@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dilip Uttamrao Wange |
| Designation |
Associate Professor |
| Affiliation |
R.A Podar Ayu.(Govt.) medical college ,Worli Mumbai 400018 |
| Address |
Kayachikitsa Department,M.A Podar Govt.(Ayu.)hospital,R.A.Podar govt. Medical(Ayu.),Worli,Mumbai 400018 Kayachikitsa Department,M.A .Podar (Ayu.)Hospital,R.A Podar govt.medical college ,Worli,Mumbai 400018 Mumbai MAHARASHTRA 400018 India |
| Phone |
9892323677 |
| Fax |
|
| Email |
drdilip.wange@gmail.com |
|
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Source of Monetary or Material Support
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| OPD No. 18 Kayachikitsa Department,M.A Podar Hospital, ,R.A Podar Govt.(Ayu.)Medical College,Dr Annie Besant Road ,Worli,Mumbai,Maharashtra, 400018,Country India.
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Primary Sponsor
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| Name |
R A Podar Govt Ayu Medical College Worli Mumbai |
| Address |
R.A Podar Govt.(Ayu.)Medical College,Worli,Mumbai 400018 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rakhi Anant Jadhav |
Mahadevi Anandilal Podar Govt. Hospital |
OPD No.18, Kayachikitsa Department, M.A Podar Govt. (Ayu)Hospital,R.A Podar Ayu. Govt. Medical College,Worli Mumbai 400018 Mumbai MAHARASHTRA |
8007545422
rajanant651997@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of Institution R.A Podar Govt.( Ayu) Medical College Worli Mumbai 400018 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVAN, (2) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVAN, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Yogratnakar uttarardha Kshudrarogachikitsa adhyay, Procedure details: Duration once a day for 28 days
Applied by mixing the lepa churna with water & applied wet ardhangula thickness & removed when not more dry not more wet.) (1) Medicine Name: Lodhradi Lepa, Reference: Yogratnkar Uttarardha Kshudraroga chikitsa adhyay, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdharasamhita Uttar khanda Adhyay No.11, Procedure details: Applying once a day
MIxed with water & adra lepa apllied ardhagula thickness over the sites of pimples and removed when not more dried and not more wet.) (1) Medicine Name: Jatiphaladi lepa, Reference: lepa, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: od, Duration: 28 Days | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Khadirashtak Kwatha, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms like Pitika over face,chest ,back And having Ruja.
Subjects who are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
The patients with the conditions like Acne Rosasea,Eczema,Steroid Induced Acne
patients with known case of Renal Impairement.
patients suffering from Autoimmune diseases (RA,SLE)
patients suffering from any life threatening disorders like Cancer,HIV etc.
patients with any undergoing Immunosuppressive treatment
pregnant and lactacting females
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1. Jatiphaladi lepa is more effective than ladhradi lepa along with khadirashtak kwatha in the management of Mukhadushika with special referance to Acne Vulgaris .
2. Lodhradi lepa is more effective than jatiphaladi lepa along with khadirashtak kwatha in the management of mukhadushika with special referance to acne vulgaris.
|
4 Weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To Review the Ayurvedic & Modern literatue on Mukhadushika with special referance to Acne Vulgaris.
2. To evaluate the efficacy among jatiphaladi lepa & lodhradi lepa along with khadirashtak kwath in the management of mukhadushiaka with special referance to acne vulgaris.
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At day 10th till 28th day |
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Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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 |
|
Date of First Enrollment (India)
|
06/04/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Ayurveda being the most ancient science which believes in three pillars, (vata,pitta and kapha )dosha , seven types of dushya and three types of Mala. The equilibrium state of normalcy of all the factors is considered as Swastha. If one of these factor gets vitiated it creates disequilibrium with the swastha ,And when such vitiation occurs at specific part of the body or organ the symptoms are also observed with respect to that part of the body or organ. In such a way when Vata,kapha and Rakta dushya gets vitiated, small or medium sized eruptions appear over the face it is diagnosed as Mukhadusika ( Mukh =Face And Dushika means which causes disfigurement over the facial surface) and these appear mostly in adolescent young age ,hence mentioned as Tarunyapitika in texts ( Acne Vulgaris) . Sometimes there may be meda accumulated inside the eruptions hence in Ashtang Hriday mukhadusika are described as Medogarbha[1], which looks like shalmali kantak hence the appearance of mukhadusika are compared with shalmali kantak. [2] Acne Vulgaris is most common disorder of Pilosebaceous glands which commonly affects the hair folicles found over the face[3] Acne vulgaris mainly affects the age group of 15year to 30 years. 90% of Adolescent boys and 80-85% of adolescent Girls get affected with Acne Vulgaris[3] There are some endocrinological disorders also causing acne Vulgaris (Hypothyroidism, PCOS in females, During menstruation in females due to surge of oestrogen hormone) and so on. There are some predisposing factors regarding Lifestyle, such as, Disturbed sleep, Consumption of junk, oily foods, etc. can cause acne over the face. Some environmental factors such as Hot and Humid Atmosphere can also aggravate the diasease. Moreover Excessive use of Cosmetic products, Oil based Local applications causes acne over the face. The presentation of Acne Vulgaris is mainly characterised in the form of Papules, pustules and Nodules( painful or painless). In Ayurvedic texts, acne vulgaris is mentioned as Mukhadushika / Tarunyapitika and Medogarbha in which the Vatadosha, Kaphadosha and Rakta dushya are vitiated .Mukhadushika is described under Kshudra rogas in Sushrut Samhita[4], Madhav nidan[5], Ashtang sangraha[6], Ashtang Hriday[7] and Sharangdhar samhita[8]. There are no as such specific etiological factors are described in texts regarding mukhadushika. As Perfect skin is, for most people, a distant dream. Chronic skin conditions typically are not curable in western system of medicine, but they can be manageable using Ayurvedic therapies and by paying close attention to our lifestyle. This case is a example of Mukhadushika like skin disease can be managed with Ayurvedic therapy. The combination of drugs selected ( Manjishtha,Patol,Sariva, Musta, Kutaki, Amalragandhi haridra, Patha )[9] will act over the pathological aspect of the disease breaking pathology as whole with maintaining the asthestic value.
Need of study It is a celebrity topic in dermatology and it is not only harming physically but mentally and socially too…. Hence it is matter of concern!!! We all have seen college going students literally going into depression , trying out all the possible ways to treat acne. Hence some or the other way they land up in buying costlier medicines. Majority of acne case if left untreated it may turn into scar formation or hyperpigmentation (PIH). only Local applications ,creams gives temporary relief but may lead to recurrence. Ayurvedic formulations given internally can act over the targeted dosha ( vata, kapha and Rakta) in order to break the pathology and treating disease as whole.
Group of patients: Group I: No. of Patients: 44 Treatment: Jatiphaladi Lepa once a day over the acne. Group II : No. of Patients: 44 Treatment: Jatiphaladi Lepa over the acne and Khadirashtak kwatha (20ml) orally twice a day. Investigations Blood CBC ,ESR,Lipid Profile, BSL Fasting and Post prandial
SUMMARY & CONCLUSION The work will be summarized to make final conclusions. Observation of result will be concluded with statistical analysis under the heading conclusion with explanation at the end of whole research. The data collected from CRF will be subjected to statistical analysis, appropriate statistical tests will be applied to the data generated and significance of improvements will be studied. |