CTRI/2026/01/100984 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On:
13/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to asses effect of lajjalu oil tampons in cervical erosion.
Scientific Title of Study
A Randomized Controlled Clinical Trial to Evaluate the Effect of Lajjalu Siddha Taila Yonipichu in the Management of Garbhashaya Mukhagat Vrana with Special Reference to Cervical Erosion.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Vd Sheela Sambhaji Chavan
Designation
Post Graduate Scholar
Affiliation
R A Podar Medical College (Ayu),Worli,Mumbai,400018.
Address
OPD No. 8, Prasutitantra–Strirog Department,
M. A. Podar Hospital,
Dr. Annie Besant Road, B Wing,
BDD Chawls, Worli,
Mumbai, Maharashtra, India – 400018 OPD No. 8, Prasutitantra–Strirog Department,
M. A. Podar Hospital,
Dr. Annie Besant Road, B Wing,
BDD Chawls, Worli,
Mumbai, Maharashtra, India – 400018 Mumbai MAHARASHTRA 413101 India
Phone
09970288380
Fax
Email
sheelachavan06092000@gmail.com
Details of Contact Person Scientific Query
Name
Vd Manoj Vitthal Gaikwad
Designation
Professor
Affiliation
R A Podar Medical College (Ayu),Worli,Mumbai,400018.
Address
1st Floor, Prasutitantra–Strirog Department,
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, B Wing,
BDD Chawls, Worli,
Mumbai, Maharashtra, India – 400018 1st Floor, Prasutitantra–Strirog Department,
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, B Wing,
BDD Chawls, Worli,
Mumbai, Maharashtra, India – 400018 Mumbai MAHARASHTRA 400018 India
Phone
9822752816
Fax
Email
drmanojvgaikwad@gmail.com
Details of Contact Person Public Query
Name
Vd Manoj Vitthal Gaikwad
Designation
Professor
Affiliation
R A Podar Medical College (Ayu),Worli,Mumbai,400018.
Address
R. A. Podar Ayurved Medical College
Dr. Annie Besant Road, B-Wing, BDD Chawls, Worli,
Mumbai, Maharashtra 400018, India. R. A. Podar Ayurved Medical College
Dr. Annie Besant Road, B-Wing, BDD Chawls, Worli,
Mumbai, Maharashtra 400018, India. Mumbai MAHARASHTRA 400018 India
Phone
9822752816
Fax
Email
drmanojvgaikwad@gmail.com
Source of Monetary or Material Support
OPD No. 8, Prasutitantra–Strirog Department,
M. A. Podar Hospital,
Dr. Annie Besant Road, B Wing,
BDD Chawls, Worli,
Mumbai, Maharashtra, India – 400018
Primary Sponsor
Name
Vd Sheela Sambhaji Chavan
Address
OPD No 8 (Prasutitantra Strirog ) M A Podar Hospital,
Dr. Annie Besant Road, B-Wing, BDD Chawls, Worli,
Mumbai, Maharashtra 400018, India.
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Vd Sheela Sambhaji Chavan
Vd Sheela Sambhaji Chavan
M A Podar Hospital ,
Dr. Annie Besant Road, B-Wing, BDD Chawls, Worli,
Mumbai, Maharashtra 400018, India.
R. A. Podar Ayurved Medical College
Dr. Annie Besant Road, B-Wing, BDD Chawls, Worli,
Mumbai, Maharashtra 400018, India. Mumbai MAHARASHTRA
09970288380
sheelachavan06092000@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
INSTITUTIONAL ETHICAL COMMITTEE RA. PODAR MEDICAL COLLEGE ,WORLI, MUMBAI 400 018.
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: VRANAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Comparator Arm
Procedure
-
yoni picu, योनि पिचु
(Procedure Reference: 29. Charaka. Charaka Samhita, Chikitsa Sthana 19/46. Edited by Pt. Jadavji Trikamji Acharya. Varanasi: Chaukhamba Surbharati Prakashan; Reprint 2020., Procedure details: Purva Karma:
Written informed consent will be obtained from the patient prior to the procedure & baseline vital parameters will be recorded. The patient will be advised to empty the bladder and rectum before the procedure. She will then be placed in a supine position with flexed knees. Yoni prakshalana will be performed using a lukewarm sterile decoction such as Triphala kwatha.
Pradhana Karma:
A sterile cotton tampon (pichu) soaked in 10 ml of warm Siddha Taila will be gently inserted deep into the vaginal canal at the Garbhashaya Mukha sthana. The attached thread will be kept outside the vaginal introitus to facilitate easy removal after the stipulated duration. The entire procedure will be carried out under strict aseptic precautions.
Paschat Karma:
The patient will be advised to remove the pichu after three hours.) (1) Medicine Name: Jatyadi Taila, Reference: 21. Sharangadhara. Sharangadhara Samhita, Madhyama Khanda 9/166.5–169. Edited by Dr. Brahmanand Tripathi. Varanasi: Chaukhamba Surbharati Prakashan; 2020., Route: Vaginal, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Duration: 7 Days
2
Intervention Arm
Procedure
-
yoni picu, योनि पिचु
(Procedure Reference: Charaka. Charaka Samhita, Chikitsa Sthana 19/46. Edited by Pt. Jadavji Trikamji Acharya. Varanasi: Chaukhamba Surbharati Prakashan; Reprint 2020., Procedure details: Purva Karma:
Written informed consent will be obtained from the patient prior to the procedure and baseline vital parameters will be recorded. The patient will be advised to empty the bladder and rectum before the procedure. She will then be placed in a supine position with flexed knees. Yoni prakshalana will be performed using a lukewarm sterile decoction such as Triphala kwatha.
Pradhana Karma:
A sterile cotton tampon (pichu) soaked in 10 ml of warm Siddha Taila will be gently inserted deep into the vaginal canal at the Garbhashaya Mukha sthana. The attached thread will be kept outside the vaginal introitus to facilitate easy removal after the stipulated duration. The entire procedure will be carried out under strict aseptic precautions.
Paschat Karma:
The patient will be advised to remove the pichu after three hours.
Duration: 3-4Hours for 7 Days.
) (1) Medicine Name: Lajjalu Siddha Taila, Reference: 29. Charaka. Charaka Samhita, Chikitsa Sthana 19/46. Edited by Pt. Jadavji Trikamji Acharya. Varanasi: Chaukhamba Surbharati Prakashan; Reprint 2020, Route: Vaginal, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Duration: 7 Days
Inclusion Criteria
Age From
19.00 Year(s)
Age To
50.00 Year(s)
Gender
Female
Details
1 Women aged 19 to 50 years will be included in the study.
2 Married women will be selected irrespective of parity.
3 Presence of cervical erosion will be confirmed on per speculum examination.
4 Women presenting with signs and symptoms such as vaginal discharge, post-coital bleeding, low backache, and dyspareunia will be included.
ExclusionCriteria
Details
1 Women who are pregnant or in the postpartum period within 6 weeks will be excluded.
2 Patients currently using oral contraceptive pills will be excluded.
3 Known cases of cervical intraepithelial neoplasia or previously treated cervical carcinoma will be excluded.
4 Patients showing malignant changes on Pap smear examination will be excluded.
5 Patients who are HIV, HBsAg, or VDRL positive will be excluded.
6 Women with intrauterine contraceptive device insertion will be excluded.
7 Patients suffering from severe systemic disorders such as uncontrolled diabetes mellitus, tuberculosis, or hypertension will be excluded.
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
1 Reduction or disappearance of Nabothian cysts, if present.
2 Restoration of cervical tone and mucosal integrity.
3 Assessment of tolerance, safety, and patient acceptability of the procedure.
4 Improvement in per speculum findings.
1 week
Secondary Outcome
Outcome
TimePoints
1 Reduction or disappearance of Nabothian cysts, if present.
2 Restoration of cervical tone & mucosal integrity.
3 Assessment of tolerance, safety, & patient acceptability of the procedure.
4 Improvement in per speculum findings.
1 week
Target Sample Size
Total Sample Size="70" Sample Size from India="70" 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)
24/01/2026
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="8" 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
Cervical erosion is common beningn condition of cervix in women of reproductive age and is associated with symptoms such as vaginal discharge,itching,dyspareunia and low backache.Conventional treatmenta like cauterization ,cryotherapy though effective,may be invasive,uncomfortable,and associated with recurrence or limited accessibility.In ayurveda ,cervical erosion can be correlated with Garbhashaya mukhgata vran .Yonipichu is locally acting therapy providing sustained drug contact and promoting mucosal healing . Lajjalu(Mimmosa pudica Linn.) possesses vranaropana , stambhana ,shothhar properties and has shown wound healing potential.
This randomized controlled clinical trail aims to evaluate the effficacy and safety of lajjalu siddha tail yonipichu compared to jatyadi tail yonipichu in patients with cervical erosion . Seventy participients will br randomized in two groups and treated for seven days in post menstrual phase .Outcomes will be assessed based on subjective symptoms and objective cervical findings to establish a safe ,cost effective and non invasive management option.