| CTRI Number |
CTRI/2025/06/089054 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effectiveness of Nilotpaladi churna in treating asrugdar(excessive menstrual bleeding) with a focus on menorrhagia |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate efficacy of Nilotpaladi churna in the management of asrugdar with special referance to menorrhagia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shital Tanaji Gavale |
| Designation |
PG scholar in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree roga evum prasuti tantra OPD No.5 and IPD, Ground floor Late Kedari Redekar Ayurvedic College, Hospital And Research Centre P2 M.I.D.C Shendri mal, Gadhinglaj-416502, District Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9284945638 |
| Fax |
|
| Email |
shitalgavale1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Uttamrao Lomate |
| Designation |
BAMS PG (Dip) Prasuti tantra avum striroga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree Roga Evum Prasuti Tantra OPD No.5 and IPD, Ground floor Late Kedari Redekar Ayurvedic College, Hospital And Research Centre P2 M.I.D.C. Shendri Mal Gadhinglaj-416502, District Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8275917687 |
| Fax |
|
| Email |
prasadlomate969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Tanaji Gavale |
| Designation |
PG scholar in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree Roga Evum Prasuti Tantra OPD No.5 and IPD, Ground floor Late Kedari Redekar Ayurvedic College, Hospital And Research Centre P2 M.I.D.C. Shendri Mal Gadhinglaj-416502, District Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9284945638 |
| Fax |
|
| Email |
shitalgavale1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College,Hospital And Research Centre P2 M.I.D.C.Shendri Mal, Gadhinglaj-416502 District-Kolhapur,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr. Gavale Shital Tanaji |
| Address |
Talegaon Road,Shivaji Nagar Near Gitai Nagar, Ahmedpur
District-Latur |
| 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 |
| DrShital Tanaji Gavale |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Stree Roga Evum Prasuti Tantra OPD No-5 and IPD,Ground Floor, Late Kedari Redekar Ayurvedic College, Hospital And Research Centre P2,M.I.D.C. Shendri Mal, Gadhinglaj-416502, District-Kolhapur,Maharashtra,India
Kolhapur
MAHARASHTRA |
9284945638
shitalgavale1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (2) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (3) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nilotpaladi churna , Reference: Vangsena chapter no-18 Mahila rog chikitsa Shlok no-43 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pushyanug Churna, Reference: Bhaishaijya Ratnavali Pradar chikitsa chapter no-66, shlok no 25-30, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-45 year women
Patients with excessive vaginal bleeding more than 4 days without having any pathogenesis
Patient with per vaginal bleeding before & after Menses without having any pelvic organ pathogenesis
Quantity of Menstrual blood must be greater than 80-100 ml/menstrual cycle
Patient with absolute symptoms of Asrugdar like
1 Atyadhik raktastrav
2 Anrutukal raktastrav
3 katishool
4 Adhodarshool
5 Sarvangmard
Patients having sign and symptoms of menorrhagia like
Excessive vaginal bleeding
Long duration of blood flow during menses
Passage of deep clots
Patient having any one of symptoms with or without bodyache, weakness, giddiness, anemia,etc.
Voluntary willing patients
Patients irrespective of religion,cast,pathy,occupation
Hb% 8 to more than 8gm% |
|
| ExclusionCriteria |
| Details |
Patients having cervical, uterine polyp
Patients having genital malignancy
Patients suffering from HIV,STD, Hepatitis B
Patients suffering from disorder like genital TB
Patients with chronic illness
Utwrine fibroid and other pelvic pathologies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Nilotpladi churna orally in the management of Asrugdar with special referance to menorrhagia |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the efficacy of Nilotpladi churna orally in the management of Asrugdar with special reference to menorrhagia
2)To compaire the Nilotpladi churna orally with Pushyanug churna orally in the management of Asrugdar with special referance to menorrhagia |
5 days |
|
|
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)
|
02/07/2025 |
| 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
|
Title Randomized controlled clinical trial to evaluate the efficacy of Nilopaladi churna in the management of asrugdar with special referance to menorrhagia
Objective To evaluate the efficacy of Nilotapaladi churna in the management of asrugdar with special reference to menorrhagia. To define asrugdar in term of heavy menstrual bleeding. To review the details of asrugdar in ayurveda literature.
Open simple randomized clinical study ,initial assesment and selection of patients 60 randomized selected patients of asrugdar will be divided in to two groups (trial group A and control group B) Each group contains 30 patients. Informed written consent will be taken from each patients prior to research Authentication and standardization of trial drug and control drug Nilotpadali churna will be done Group A Group B (Trial Group) (Control Group) 4gm Nilotapaladi churna TDS 4gm Nilotapaladi churna TDS for 3 cosecutive menstrual cycle in for 3 consecutive menstrual cycle in apankal with anupan honey apankal with anupan tandulodak or honey Observation will be done up to 3 consequent menstrual cycle starting from 1st menstrual cycle of treatment To trial group A Nilotapaladi churna will be give for 3 months To control group B Pushyanug churna will be give for 3 months All observed changes will be recorded Follow up on 1st, 3rd, 5th day of menstrual cycle for 3 cycle obsevation , Discussion, Conclusion , Summary
|