| CTRI Number |
CTRI/2025/07/092098 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of Ayurvedic Enema in painful periods (Primary Dysmenorrhea) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Aarohana And Sadharana Krama Matrabasti In The Management of Udavartini 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 Bhanu B V |
| Designation |
PG Scholar |
| Affiliation |
Ramakrishna Ayurvedic medical college, Hospital and Research Centre |
| Address |
Department of Panchakarma in PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre,Bangalore. 54/2,Ramagondanahalli, Yelahanka, Bangalore, 560064
Bangalore
KARNATAKA
560064
India |
| Phone |
8296710989 |
| Fax |
|
| Email |
bhanubv99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi R |
| Designation |
HOD |
| Affiliation |
Ramakrishna Ayurvedic medical college,Hospital and Research Centre, Bangalore. |
| Address |
Department of Panchakarma in PG Studies, Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, Bangalore.
54/2,Ramagondanahalli, Yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9886716509 |
| Fax |
|
| Email |
ayurray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi R |
| Designation |
HOD |
| Affiliation |
Ramakrishna Ayurvedic medical college,Hospital and Research Centre, Bangalore. |
| Address |
Department of Panchakarma in PG Studies, Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, Bangalore.
54/2,Ramagondanahalli, Yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9886716509 |
| Fax |
|
| Email |
ayurray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, 54/2,Ramagondanahalli, Yelahanka, Bangalore 560064 |
|
|
Primary Sponsor
|
| Name |
Dr Dishin M Vaghani |
| Address |
Ramakrishna Ayurvedic Medical college, Hospital and Research Centre, 54/2,Ramagondanahalli, Yelahanka, Bangalore 560064 |
| 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 Bhanu B V |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre. |
Department of Panchakarma in PG Studies, 54/2,Ramagondanahalli, Yelahanka, Bangalore 560064
Bangalore
KARNATAKA |
8296710989
bhanubv99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical College, Hospital and Research Centre Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Shri Chakrapanidatta - Chakradatta with Vidyaprabha hindi commentary edited by Ramnath Dwivedi,Chaukambha Sanskrit Sanstan,Varanasi 1992,Chakradatta chapter 72 verse 4 p.no -448, Procedure details: Sadharana krama Matra Basti daily 1 basti for 9 days. )
(1) Medicine Name: Moorchita Tila Taila , Reference: Acharya Sushrta- Sushruta samhita,elaborated by Acharya Sushruta with Nibandha Sangraha Commentary by Dalhana Edited by Acharya Priyavarta Sharma, Choukhamba orientalia Varnasi,2023,Sushruta Samhita Sutrastana 45th Chapter verse 112;p.no -205, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 9 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Shri Chakrapanidatta - Chakradatta with Vidyaprabha hindi commentary edited by Ramnath Dwivedi,Chaukambha Sanskrit Sanstan,Varanasi 1992,Chakradatta chapter 72 verse 4 p.no -448, Procedure details: Aarohana krama Matra Basti daily 1 basti for 9 days starting from 24ml on 1st day to 72ml on 9th day.)
(1) Medicine Name: Moorchita tila taila , Reference: Acharya Sushrta- Sushruta samhita,elaborated by Acharya Sushruta with Nibandha Sangraha Commentary by Dalhana Edited by Acharya Priyavarta Sharma, Choukhamba orientalia Varnasi,2023,Sushruta Samhita Sutrastana 45th Chapter verse 112;p.no -205, Route: Rectal, Dosage Form: Taila, Dose: 24(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Age - 18 to 25 yrs.
2.Who are fit for Basti.
3.Patients coming with the chief complaint of painful menstruation.
4.Patient who are ready to sign the IC form. |
|
| ExclusionCriteria |
| Details |
1.Patients with chronic systemic illness like CVD, Uncontrolled HTN.
2.Any uterine pathology– Uterine fibroid, adenomyosis, endometriosis, uterine malformations.
3.Patient,s who are unfit for Basti. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain during Menstrual cycle. |
90 days.3 menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/08/2025 |
| 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="2"
Months="6"
Days="7" |
|
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
|
This is a randomized comparative clinical study designed to evaluate the effect of aarohana Krama Matra Basti and Sadharana Krama Matra Basti in the management of Udavartini Yonivyapad with special reference to Primary Dysmenorrhea. Primary dysmenorrhea is a common gynecological condition characterized by painful menstruation without any pelvic pathology. In Ayurveda, it is correlated with Udavartini, a Vataja Yonivyapad, caused due to Pratiloma Gati of Vata.
Matra Basti is a type of Sneha Basti indicated especially in Vataja disorders and can be used safely even in delicate individuals. The study compares two methods of administration: Aarohana Krama (gradual dose escalation) and Sadharana Krama (fixed dose) to assess their efficacy in reducing pain severity, duration of pain, and associated symptoms.
Participants will be randomly allocated into two groups, each receiving one type of Matra Basti for 9 consecutive days, starting after cessation of menstruation. Observations will be recorded for at least three menstrual cycles. The primary outcome will be reduction in pain intensity assessed by Visual Analogue Scale (VAS). |