| CTRI Number |
CTRI/2025/07/091056 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the effectiveness of Saindhavadi taila pichu in treating Dysmenorrhoea. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trail to evaluate efficacy of Saindhavadi tail pichu in the management of Udavarta Yonivyapad with special reference Dysmenorrhoea. |
| 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 Shobha Raghunath Rupnar |
| Designation |
PG scholar |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalay Gadhinglaj tal - Gadhinglaj dist- kolhapur Maharashtra |
| Address |
Late kedari redekar ayurvedic mahavidyalay,prasutitantra and streeroga department OPD no. 05, Gadhinglaj tal - Gadhinglaj dist- kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7499705081 |
| Fax |
|
| Email |
shobharupnar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Thorat |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj Kolhapur |
| Address |
Late kedari redekar ayurvedic mahavidyalay, Prasutitantra and Streeroga department OPD no 5, Gadhinglaj tal - Gadhinglaj dist- kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Thorat |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj Kolhapur |
| Address |
Late kedari redekar ayurvedic mahavidyalay, Prasutitantra and Streeroga department OPD no. 5, Gadhinglaj tal - Gadhinglaj dist- kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late kedari redekar ayurvedic mahavidyalaya, Prasutitantra and Streeroga department, OPD no 05, P-2, M.I.D.C. area Tal-Gadhinglaj, Dist- Kolhapur, state- Maharashtra , Country- India. Pin - 416502 |
|
|
Primary Sponsor
|
| Name |
Dr shobha Rupnar |
| Address |
Late kedari redekar ayurvedic mahavidyalaya, Prasutitantra and Streeroga Department OPD n0-05,P-2, M.I.D.C. area Tal- Gadhinglaj ,Dist- Kolhapur, State - Maharashtra, Country- India. PIN- 416502 |
| 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 Shobha Rupnar |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj,Kolhapur |
Prasutitantra and Streeroga department OPD no- 05, P-2, M.I.D.C. area Tal-Gadhinglaj dist-kolhapur,Maharashtra Country- India, PIN-416502
Kolhapur
MAHARASHTRA |
7499705081
shobharupnar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate research Centre,Gadhinglaj. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak Samhita, Procedure details: Saindhav,tagar,kushtha,devdaru,bruhati kalka in equal amounts is mixed with tiltail to boil it to 1/4th of its total amount.(tail siddhi) Pichu of 4x1x2 anguli is made with cotton annd gauze (pichu nirman) Tiltail soaked pichu is placed in vagina. Repeat once a day for 7 days for 3 consecutive menstrual cycles.(D6-D12))
| | 2 | Comparator Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak Samhita, Procedure details: Dashmula kalka in equal amounts is mixed with tiltail to boil it to 1/4th of its total amount.(tail siddhi) Pichu of 4x1x2 anguli is made with cotton annd gauze (pichu nirman) Tiltail soaked pichu is placed in vagina. Repeat once a day for 7 days for 3 consecutive menstrual cycles.(D6-D12))
|
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married womens
2.Having signs and symptoms of udavarta yonivyapad
3.Patients with scanty menses or average menstrual flow. |
|
| ExclusionCriteria |
| Details |
1.Patients having irregular menses
2.Patients having abnormal pelvic findings
3.Patients having congenital anomalies of reproductive tract |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Saindhavadi tail pichu is effective in udavarta yonivyapad |
once a day for 7 days for 3 consecutive menstrual cycles (from 6th day to 12th day of the cycle) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Saindhavadi taila pichu with Dashmoola Taila pichu in udavarta yonivyapada w.s.r.to dysmenorrhoea |
once a day for 7 days for 3 consecutive menstrual cycles (from 6th day to 12th day of the cycle) |
|
|
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)
|
17/07/2025 |
| 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
|
Udavarta is derived from Ud + avarta that is upward direction by aggrevated apana vayu due to obstruction in normal flow in pakwashaya, the cheif site of apana vayu itself. There are many treatment, formulation abouts udavarta yonivyapad in ayurveda.here I will study the effect of saindhavadi tail pichu in management of udavarta yonivyapad Saindhavadi tail is vatahar and has ushna veerya . |