| CTRI Number |
CTRI/2026/03/105497 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Effect of Saptachakra Churna and Shatpushpa Churna in the Management of Painful Menstruation. |
|
Scientific Title of Study
|
A Comparative Clinical Trial to Evaluate the Efficacy of Saptachakra Churna and Shatpushpa Churna in the Management of Kashtartava W.S.R. to Primary Dysmenorrhea. |
| 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 Aishwarya Arun Bhavsar |
| Designation |
PG scholar |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of streerog Avum prasutitantra,SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8669040808 |
| Fax |
|
| Email |
bhavsaraishwarya1105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Shinde |
| Designation |
Professor and HOD |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of streerog Avum prasutitantra,SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit shinde |
| Designation |
Professor and HOD |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of streerog Avum prasutitantra,SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
|
Source of Monetary or Material Support
|
| SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune Road,opposite to Prasad Hotel,Dist Ahmadnagar 422605 India |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Arun Bhavsar |
| Address |
Department of Streerog Avum prasutitantra, SST Ayurved Mahavidyalaya Sangamner, Nashik Pune Road,opposite to Prasad Hotel, Dist.Ahmadnagar 422605 India |
| 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 Aishwarya Arun Bhavsar |
SST Ayurved College Sangamner Ahmadnagar |
OPD division 1st floor, room number 1 ,Streerog Avum Prasutitantra OPD,SST Ayurved College Sangamner,Nashik Pune road,opposite Prasad hotel,Ahmadnagar
Ahmadnagar
MAHARASHTRA |
8669040808
bhavsaraishwarya1105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SST Ayurved Mahavidyalaya Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa churna, Reference: Kashyap sanhita ,kalpsthana shatpushpashatavari kalpaadhayay 5,6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptachakra churna, Reference: Dravyagun vigyan priyavatsharma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Nulliparous women in reproducive age group with Regular menstrual cycle and Having minimum any 3 signs and symptoms of dysmenorrhea for more than 3 consecutive cycles i.e
i)Painful period
ii)Pain in the lower abdomen.
iii)Lower backpain
iv)Fatigue
V)Nausea. |
|
| ExclusionCriteria |
| Details |
1. K/C/O Any serious systemic disease.
2. K/C/O congenital abnormalities that cause Kashtartava in relation to primary dysmenorrhea.
3.K/C/O of dysmenorrhea with any uterine pathological condition
K/C/O Adenomyosis, endometrial polyp, uterine fibroid, and endometriosis
4. K/C/O Inflammatory disorders of the pelvis.
5. Those undergoing hormone therapy.
6. K/C/O STD’s (sexually transmitted disorders). |
|
|
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 |
To Decrease the duration of
menstrual pain, Intensity of pain in lower abdomen,Intensity of backpain,fatigue,and nausea |
Total duration of treatment -12 weeks
Assessment on 1st day, day 5 of 1st,2nd,3rd menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/03/2026 |
| 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="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 -“A Comparative Clinical Trial to Evaluate the Efficacy of Saptachakra Churna and Shatpushpa Churna in the Management of KashtartavaW.S.R. to Primary Dysmenorrhea.”
INTRODUCTION -Several studies in India found that the prevalence of dysmenorrhea was 77%.It is still unknown what causes uterine pain in primary dysmenorrhea. However, a number of risk factors have been found, including smoking, stress/depression, nulliparity, early menarche, young age, and positive family history. In ayurveda Saptchakra (Salacia chinensis) Churna and Shatapushpa (Anethum graveolens) Churna are indicated in Kashtartavahara. Both these drugs are proven earlier but their comparative efficacy is not yet explored Hence study has been planned entitled ‘Comparative Clinical trial to evaluate the effect of Saptchakra Churna and Shatpushpa Churna in the management of Kashtartava W.S.R. to Primary Dysmenorrhea.’
SAMPLE SIZE -Total sample size for study will be 80 participants divided equally between 2 groups.
NULl HYPOTHESIS (H0)-There is no statistically significant difference in the efficacy of Saptachakra Churna and Shatpushpa Churna in the management of Kashtartava W.S.R to Primary Dysmenorrhoea.
Alternate Hypothesis (H1)-There is statistically significant difference in the efficacy of SaptchakraChurna and Shatpushpa Churna in the management of Kashtartava W.S.R. to Primary Dysmenorrhea |