| CTRI Number |
CTRI/2026/01/100364 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinically study between effect of Krushnatil kwath and krushntil tail rectally on OLigomenorrhea |
|
Scientific Title of Study
|
An Open Label Randomized Comparative Clinical Study To Evaluate The Efficacy Of Krushnatila Kwath Orally And Krushnatil Taila Matra Basti In The Management of Artavakshaya With special reference to Oligomenorrhea |
| 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 Ashvini Subhashrao Bade |
| Designation |
Assistant Professor |
| Affiliation |
DR J J Magdum Ayurved Medical College |
| Address |
Stree-rog Prasuti Tantra Department
2nd floor
room no 3
Dr J J Magdum Ayurved Medical College
Gat NO 295
Shirol wadI road
Tal shirol
Dist Kolhapur
416101
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
7522926360 |
| Fax |
|
| Email |
badeashwini49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyshri Mahavir Khot |
| Designation |
professor |
| Affiliation |
R A Podar Ayurved Medical College and M A Podar Hospital Worli Mumbai |
| Address |
Stree-rog Prasuti Tantra Department
1nd floor
room no 1
R A Podar Ayurved Medical College and M A Podar Ayurved Hospital
Dr Annie Besant Road Worli
Mumbai
400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9850539489 |
| Fax |
|
| Email |
khotbhagyashri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyshri Mahavir Khot |
| Designation |
professor |
| Affiliation |
R A Podar Ayurved Medical College and M A Podar Hospital Worli Mumbai |
| Address |
Stree-rog Prasuti Tantra Department
1nd floor
room no 1
R A Podar Ayurved Medical College and M A Podar Ayurved Hospital
Dr Annie Besant Road Worli
Mumbai
400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9850539489 |
| Fax |
|
| Email |
khotbhagyashri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr J J Magdum AYurved Medical college And Hospital
Gat no 295
Shirol wadi road
Jaysingpur
416101 |
|
|
Primary Sponsor
|
| Name |
Ashvini Subhashrao Bade |
| Address |
Dr J J Magdum Ayurved Medical College
Gat NO 295
Shirol wadI road
Tal shirol
Dist Kolhapur
416101 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashvini Bade |
DR J J Magdum Ayurved college Hospital .Jaysingpur |
Stree Rog Prasuti Tantra opd
room no 3
ground floor
Dr J J MAgdum Ayurved college hospital
shirol wadi road
Jaysingpur
416101
Kolhapur
MAHARASHTRA |
7522926360
badeashwini49@gmail.com |
| Dr Bhagyashri Khot |
R A podar Ayurved Medical college and M A podar Ayured Hospital worli |
Stree Rog Prasuti Tantra opd
room no 7
ground floor
M A podar Ayurved Hospital
annie besant road
worli mumbai 400018
Mumbai
MAHARASHTRA |
9850539489
khotbhagyshri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITEE |
Approved |
| INSTITUTIONAL ETHICAL COMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N912||Amenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Krushnatil Tail , Reference: gadnigrah pradar pushpati nash chiitsa adhyay 56, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: krushnatil tail 60 ml matra basti rectaly give in apan kal for 7 days from 21st day of menstruation,This should be given for 3 consecutive menstrual phase | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krushnatil kwatha, Reference: gadnigrah pradar pushpati nash chiitsa adhyay 56, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Krushnatil kwath 4o ml twice in a day after food orally from 21st day of menstruation. This should give for 3 consecutive menstruation phage |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
patients suffering with two or more cardinal symptoms of Artavakshaya
Patient Associated of Polycystic ovarian morphology |
|
| ExclusionCriteria |
| Details |
Pregnant And Lactating women
Women ON oral contraceptive pill and Intrauterine Contraceptive Devices
Congenital anomalies of uterus or ovaries
Patients with systematic disease like Hypertension Diabetes Mellites Tuberculosis
Women with pelvic Pathology and Malignancy
Haemoglobin less than 8gm
Patients contraindicated for Matrabasti |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
study the efficacy of krushnatil kwath on artavkshay
study the efficacy of krushnatil tail matra basti on artakshay |
12 to 15 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the efficacy of krushntil kwath and krushnatil tail matra basti on artavkashy |
12 to 15 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| 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="2"
Months="0"
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
|
This is open label randomized comparative clinical study Group A patient will treated by Krushntil kwath 40 ml twice in a day orally for 7 days from 21st day of menstruation phage in three consecutive menstrual cycles in Artavkshya . Group B patient will treated by krushnatil tail matra basti 60 ml rectally for 7 days from 21st day of menstruation phage in three consecutive menstrual cycles in Artavkshay after collected data appropriate statistical test will apply and result will drown. |