| CTRI Number |
CTRI/2022/04/041814 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
06/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to know the effect of two ayurvedic medicines namely dadruhar lepa and
raktamokshana (jalaukavcharana)along with Nimba~patola patra kwath in management of dadru w.s.r to tinea |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy of Dadruhar Lepa and Raktamokshana (Jalaukavcharana) Along With Nimba-Patolapatra Kwath In The Management Of Dadru wsr To Tinea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Sharma |
| Designation |
PG scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital karol bagh New Delhi |
| Address |
Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
8684847134 |
| Fax |
|
| Email |
324diksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
H.O.D Kaya Chikitsa, Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital karol bagh New Delhi |
| Address |
Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
H.O.D Kaya Chikitsa, Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital karol bagh New Delhi |
| Address |
Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi |
| Type of Sponsor |
Government medical college |
|
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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 Diksha Sharma |
Ayurvedic and Unani Tibbia College and Hospital |
Dept. of Kayachikitsa
Ayurvedic and Unani Tibbia College and Hospital
Karol Bagh New Delhi
Central
DELHI |
8684847134
324diksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee AUTCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushruta Samhita, Procedure details: Jalaukavcharan will be performed at intermittent period of 7 days for 12 weeks)
(1) Medicine Name: Nimba Patola Patra, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 12 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimba Patola Patra, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -(2) Medicine Name: Dadruhar lepa, Reference: Rastantrasaar v Sidhaprayog Sangrah, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimba Patola Patra, Reference: Charak samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the trial and sign the consent form.
2. The patients between the age group of 18 to 60 years in either sex.
3. Patients of Dadru with features mentioned in subjective parameters.
4. Patient already taking modern medicine (Antifungals)& Local applications.
5. Patient having Potassium hydroxide (KOH) scrapping test positive
|
|
| ExclusionCriteria |
| Details |
1. Patients who were not willing for trial or fail to give consent.
2. Patients suffering from any other systemic illness,liver disorder, tuberculosis,bleeding disorder etc.
3. Pregnant and lactating women.
4. Patients taking antibiotic therapy for any systemic illness within 2 months.
5. H/O of hypersensitivity of any trial drug.
6. Allergic reaction to active substances of the leech such as hirudin,calin,hyaluronidase,egline,kollagenage,apyrase,destabilase,piyavit etc.
7. Patients with genetic and endocrinal disorder, chronic disorder like paralysis, cancer, renal failure, hepatic failure and IHD.
8. Patients having Tinea manuum and Tinea unguim.
9. Raktamokshana (jalaukavcharana)will not be done in Patients having diabetes mellitus.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters.
Raga (Inflammation)
Pidika (Eruption)
Daha (Burning sensation)
Rookshata (Dryness)
Udgata mandal (Elevated lesion) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done clinically on basis of decrease in subjective parameters of dadru |
12 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [324diksha@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
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Brief Summary
|
Skin is considered as largest sense organ of the body and has many different functions. The skin functions in thermoregulation, protection, metabolic functions and sensation. Its size and external location makes it susceptible to wide variety of disorders. In recent years, there has been a considerable increase in incidence of skin disease in tropical and developing countries like India. All the skin diseases in Ayurveda have been classified into Mahakustha and Kshudra Kustha. Dadru is one among the Kustha. Acharya Charak has included Dadru in Khsudra Kustha, whereas Acharya Sushruta and Acharya Vagbhata have explained under Mahakustha. It involves the clinical features like Kandu, Deergapratana, Utsanna, Mandala, Raaga, Pidika which exhibits involvement of Kapha and Pitta. Acharaya Vagbhata especially mentioned Dadru as Anusangika. Acharaya Dalhana classified Dadru into Sitha and Asitha. Acharaya not explained separate Nidana for Dadru kustha. Ayurvedic Classics have considered each type of Kustha to be a Tridoshaja manifestation where Rasa, Rakta, Mamsa and Ambu are the main Dusya. Dadru, one of the most common but miserable variety of Kustha affects the population of all age group. On the basis of clinical appearance Dadru Kustha mostly simulates with ‘dermatophytosis.’ The dermatophytes are a group of closely related fungi that have the capacity to invade keratinized tissue (skin, hair, and nails) of humans and other animals to produce an infection, dermatophytosis, commonly referred to as ringworm. The infections caused by a dermatophyte (species of fungi belonging to the genera Trichophyton, Microsporum, or Epidermophyton) are referred to as Tinea. |