| CTRI Number |
CTRI/2025/03/082168 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| 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
|
To study effectiveness of Ajmoda Churna in the management of
painful menstruation in age group 18 to 35 years |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Ajmoda churna in the management of
kashtartava in age group 18 to 35 years |
| 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 Sneha Chandrashekhar Waghmode |
| Designation |
PG Scholor |
| Affiliation |
PDEAs Of Ayurved And Research Center Nigdi Pune |
| Address |
Department of Stree Rog Prasutitantra PDEAs college Of Ayurved
And Research Centre Sector 25 Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
India
Pune MAHARASHTRA 411044 India |
| Phone |
8888763600 |
| Fax |
|
| Email |
snehawaghmode97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vinayak Shinde |
| Designation |
Professor |
| Affiliation |
PDEAs Of Ayurved And Research Center Nigdi Pune |
| Address |
Department of Stree Rog Prasutitantra PDEAs college Of Ayurved
And Research Centre Sector 25 Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
India
Pune MAHARASHTRA 411044 India |
| Phone |
9850933512 |
| Fax |
|
| Email |
drvkshinde@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sneha Chandrashekhar Waghmode |
| Designation |
PG Scholor |
| Affiliation |
PDEAs Of Ayurved And Research Center Nigdi Pune |
| Address |
Department of Stree Rog Prasutitantra PDEAs college Of Ayurved
And Research Centre Sector 25 Nigdi Pune Maharashtra 411044
Pune
MAHARASHTRA
India
Pune MAHARASHTRA 411044 India |
| Phone |
8888763600 |
| Fax |
|
| Email |
snehawaghmode97@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Center Sector 25 Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAS College Of Ayurved and Research Center Nigadi Pradhikaran Pune |
| Address |
Department of Stree Rog Prasutitantra PDEAs college Of Ayurved
And Research Centre Sector 25 Nigdi Pune Maharashtra 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Sneha Chandrashekhar Waghmode |
PDEA Ayurved Rugnalaya And Sterling Multispecialty Hospital |
OPD No 119 Streerog
and Prasutitantra
Department Nigdi Pradhikaran
Pune 411044
Maharashtra
Pune
MAHARASHTRA Pune MAHARASHTRA |
8888763600
snehawaghmode97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R398||Other symptoms and signs involvingthe genitourinary system. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients Complaining of Painful Menstruation for at least 2 Consecutive Cycles
2)Age group 18 to 35 years
3)Married Unmarried Patients having Regular Menstrual Cycle |
|
| ExclusionCriteria |
| Details |
1) Irregular Periods
2) Heavy and Excessive Periods
3) Patient having Pelvic Pathology Endometriosis PID Tuboovarian mass Adenomyosis Cystitis
4) Patient with IUCD OC pills
5) Disease Related to Uro genital System
6) Patient having Uterine Pathology Uterine fibroid Endometriosis
7) Patient taking any hormonal Therapy
8) Patient taking NSAID |
|
|
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 |
clinical study to evaluate the efficacy of
Shatpushpa Churna and Ajmoda Churna in the management of Kashtartava of follow
up wise result before and after treatment in the
management of Kashtartava with the help of
case record proforma and clinical examination
for 3 Months |
3 months treatment with 3 follow ups on 1st, 2nd,
3rd (4th or 5th Day) menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect if any |
3 Months (1st, 2nd, 3rd consecutive menstual
cycles) |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
20/03/2025 |
| 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
|
Kashtartava is the symptom mention in various Yonivyapadas . Vata being the main causative factor for this condition as painful menstruation. It is commonly compaired with Dysmenorrhea of modern science and commonest of all gynecological complaints the menstrual blood flow is mainly under the control of Apana vayu vitiated Vata dosha the main causative factor of Kashtartava. All the four factor Rutu ( Fertile period ) Kshetra ( female genital organ or whole body),Ambu(ahar rasa),Beeja(sperm and ovum)are affected by the Kashtartava. the process of Rajpravartana is affected by age,occupation,social staus ,nutrition,the work place and mode of working ,heavy and stressed working schedules eg.factory workers, IT sectors ,professions needs to maintain high physique like armed forces,defence Women suffer from many disturbances naturally which commonly go unnoticed, among which menstrual pain stands most important. Every month majority of women experience various symptoms attributed to their menstrual cycle. Dysmenorrhea being the most common among them . Dysmenorrhea is defined as painful menstruation is one of sufficient magnitude so as to incapacitate day to day activities . it is usually primary and associated to normal ovulatory cycles and no pelvic pathology more than 50% of menstruating women, teenagers suffers from primary dysmenorrhea out of more than 15% suffer this pain for 1-3 days or starting first 1-2 days or may be atleast one day of menstrual cycle. Pain is body’s most important alarm symptom. It draws attention to the fact, that should be noticed and bring patient for consultation. Total absence of pain or having mild pain do not make patient that much conscious to visit hospital. However uncontrolled pain is the single most common reason for people seek medical advice. Conventional treatment of dysmenorrhea consist of Non-Steroidal Anti Inflammatory Drugs,hormonal therapy,which causes side effects. Ayurvedic herbo-mineral ,non hormonal ,nontoxic preparations are proved effective in dysmenorrhea. The drug Ajmoda churna mentioned in Dhanvantari Nighantu effective in the Management of Kashtartava. |