| CTRI Number |
CTRI/2025/08/093508 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [siravedh blood letting through cubital vein] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate effect of siravedh (blood letting ) given with Mahamanjisthadi kwath by oral route ant Lodhradi lepa for local application in Acne vulgaris (Yuvanpodika) |
|
Scientific Title of Study
|
Open labelled randomized controlled clinical trial to evaluate the add on effect of Siravedh with Mahamanjisthadi kwath internally and Lodhradi lepa local application in Yuvanpidika 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 |
vibhavari Tukaram Kokane |
| Designation |
PhD scholar |
| Affiliation |
Late kedari Redekar Ayurvedic Mahavidhalaya Post Graduate Training and research center gadhinglaj |
| Address |
Late kedari Redekar Ayurvedic Mahavidhalaya Post Graduate Training and research center Kayachikitsa Deparment 1st floor gadhinglaj p-2 MIDC area shendri mal Gadhinglaj
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420326846 |
| Fax |
|
| Email |
vibhavari.kokane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasundhara Ramdas Borakhade |
| Designation |
Associate Professor PhD guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kayachikitsa Department 2nd floor Room number 2 Kodoli Taluka Panahala
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822885710 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vibhavari Tukaram Kokane |
| Designation |
PhD scholar |
| Affiliation |
Late kedari Redekar Ayurvedic Mahavidhalaya Post Graduate Training and research center gadhinglaj |
| Address |
Late kedari Redekar Ayurvedic Mahavidhalaya Post Graduate Training and research center kayachikitsa department 1st floor gadhinglaj p-2 MIDC area shendri mal Gadhinglaj
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420326846 |
| Fax |
|
| Email |
vibhavari.kokane@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vibhavari Tukaram Kokane |
| Address |
kayachikitsa department Late Kedari Redekar Ayurvedic Mahavidhalaya Post Graduate Training and Research Centre p-2 MIDC area shendri mal Gadhinglaj Taluka Gadhinglaj District Kolhapur 416502 state Maharashtra Country India |
| 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 |
| Dr Vibhavari Tukaram Kokane |
Late Kedari Redekar Ayurvedic Mahavidhalaya Gadhinglaj Post Graduate Training and Research Center |
Kayachikitsa Out patient Department,Room No 01,ground floor P-2 MIDC area shendri mal Gadhinglaj taluka Gadhinglaj 416502
Kolhapur
MAHARASHTRA |
9420326846
vibhavari.kokane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurved College Post Graduate Training and Research Center kodoli |
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 | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Chakradatta kshudraroga chikitsa 55/41, Procedure details: (Procedure Reference: Chakradatta Kshudraroga chikitsa55/41, Procedure details: Operational procedure for Siravedh patient will be screened according inclusion criteria. written informed consent of patient will be taken. Advice to take liquid diet. Required material Sterile disposable scalp vein set no 18.sphyggmanomataer,cotton spirit disposable gloves ,measuring glass. Pradhan karma In lying down position blood pressure will check. Tie the Tourniquet 4 angul above sira(cubital fossa) neither too tight or too loose and ask patient to fist. Clean at cubital fossa with spirit swab. Puncture cubital vein with sterile disposable scalp no 18 Measuring glass is used for collecting blood. After 152 ml blood collection release the tourniquet. Remove the scalp. Apply the sterile antiseptic banadage on the prick site.Advice to take test for 20 -30 minute to the patient. Siravedh kal suitable time (Sushrut sharir sthan 8/7,10) In rainy season -when days are not cloudy. In summer season -in cold time In Hemant season -Midday))
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar samhita uttarkhand 11/11, Procedure details: Material
Lodhra powder 1 part,Dhnyak beej powder 1 part,Vacha powder 1part.
coton, water, Napkin, bowl.
Prepartion of lepa . 2gm powder take in bowl add room temperature water according to necessity.Stirr the mixture well till the paste form.
Before apply wash th face wiyh water.
Pradhan karma
Apply the prepared lepa in the opposite direction of hair follicles .
apply lepa in the moening.After application patienr can lye down or sit in comfortable position. Wash out the lepa with water before it gets completely dry.
Avoid application of other cream ,gel ,facewash)
| | 3 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhara samhita uttarkhand 11/11, Procedure details: (Procedure Reference: Sharangdhar samhita uttarkhand 11/11, Procedure details: Material Lodhra powder 1 part,Dhnyak beej powder 1 part,Vacha powder 1part. coton, water, Napkin, bowl. Prepartion of lepa . 2gm powder take in bowl add room temperature water according to necessity.Stirr the mixture well till the paste form. Before apply wash th face wiyh water. Pradhan karma Apply the prepared lepa in the opposite direction of hair follicles . apply lepa in the moening.After application patienr can lye down or sit in comfortable position. Wash out the lepa with water before it gets completely dry. Avoid application of other cream ,gel ,facewash)))
| | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi kasahya bruhat, Reference: Bharat Bhaishjya Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sama bhag jala), Additional Information: - | | 5 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi kwath Bruhat, Reference: Bharat Bhaishajya Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sama bhag jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 patients having classical sign and symptom of yuvanpidika,kandu,Ruja,Shotha,srava,vaivarnya,over face.
2.patients having Hb percentage more than 10 Gram |
|
| ExclusionCriteria |
| Details |
1 Patients having bleeding disorder
2 Patients suffering from other skin disorder
3 Patients having systemic disease like Diabetes Mellitus HIV
4 pregnant women and lactating women
5Patients having other types of Acne |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the add on effect of Siravedh 152 milliliter with Mahamanjisthadi Kwath and Lodhradi lepa in Yuvanpidika |
subjective and objective parameter will be assessed on baseline 16th and 30 th day of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study probable mode of action of Siravedh with Mahamanjishtadi Kwath Lodhradi lepa in Yuvanpidika |
subjective and objective parameter will be assessed on baseline 16th and 30 th day of study |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="6"
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
|
In present study attempt will be made for Group A to understand Add on effect of Siravedh 152 ml through cubital vein on 0 day along with Mahamanjishtadi kwath 20 ml two times a day after meal and Lodhradi lepa once a day local application for 30 days .And for Group B Mahamanjishtadi kwath 20 ml two times a day after meal and Lodhradi lepa once a day local applicaion for 30 days.
In Charak samhita Kustha chikitsa acharya expound about Lepa that the external application succeed when are applied after proper administration of Shodhan therapy to the patient. After Raktamokshan -siravedh recurrence of disease is prohibited.And lepa after shodhan is works effectively. |