CTRI

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CTRI Number

CTRI/2026/01/100764 [Registered on: 09/01/2026] Trial Registered Prospectively

Last Modified On:

09/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Study To Asssess The Effect Of Matra Basti With Bala Taila Along With Maharasnadi Kwatha And Yograja Guggulu In Adenomyosis

Scientific Title of Study

Efficacy Of Matra Basti With Bala Taila Along With Maharasnadi Kwatha And Yograja Guggulu Orally In The Management Of Vataja Yoni Vyapada Adenomyosis A Single Arm Clinical Trial

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sabia
Designation	PG Scholar
Affiliation	ALL INDIA INSTITUTE OF AYURVEDA HOSPITAL
Address	405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India 405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India South DELHI 110076 India
Phone	9582021251
Fax
Email	msabiasiddiqui@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Swati Gaikwad
Designation	Associate Professor
Affiliation	ALL INDIA INSTITUTE OF AYURVEDA HOSPITAL
Address	405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi South DELHI 110076 India
Phone	9270825656
Fax
Email	swativgaikwad369@gmail.com

Details of Contact Person
Public Query

Name	Sabia
Designation	PG Scholar
Affiliation	ALL INDIA INSTITUTE OF AYURVEDA HOSPITAL
Address	405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India 405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India South DELHI 110076 India
Phone	9582021251
Fax
Email	msabiasiddiqui@gmail.com

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	ALL INDIA INSTITUTE OF AYURVEDA
Address	405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Sabia	OPD 203 ALL INDIA INSTITUTE OF AYURVEDA	405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India South DELHI	09582021251 msabiasiddiqui@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIA INSTITUTIONAL ETHICS COMMITTE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N858\|\|Other specified noninflammatory disorders of uterus. Ayurveda Condition: VATAJA-YONIROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Maharasnadi Kwatha , Reference: शार्ङ्गधरसंहिता मध्यम खण्ड अध्याय - ७ , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -nil
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Yograja guggulu-, Reference: शार्ङ्गधरसंहिता मध्यम खण्ड अध्याय - ७ , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -nil
3	Intervention Arm	Procedure	-	mAtrAbastiH, मात्राबस्तिः	(Procedure Reference: अष्टाङ्गहृदयम् चिकित्सास्थान ,अध्याय-२१ वातव्याधि, Procedure details: For 7 days for 3 consecutive cycles) (1) Medicine Name: Bala taila, Reference: अष्टाङ्गहृदयम् चिकित्सास्थान ,अध्याय-२१ वातव्याधि., Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months

Inclusion Criteria

Age From	25.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	Diagnosis of adenomyosis confirmed by USG Pelvis or TVS Or MRI Pelvis Patient willing to participate in the study and adhere to the treatment protocol Patient presenting with any of complaints of yonishoola toda and vedana of yoni pricking and other pain of vagina Yoniruksh dryness in vagina and Yoni Stambham that is stiffness in vagina and uterus

ExclusionCriteria

Details

Patient having any systematic disease like Diabetes Hypertension severe anemia Hb less than 7 gm per dl
Pregnant women
Congenital anomaly of reproductive tract
Patient having any type of malignancy
Acute inflammatory disease like acute PID sexually transmitted disease like HIV VDRL HBsAg HCV positive females Patient using oral contraceptive pills and intra uterine contraceptive device
Patient with thyroid hormone abnormalities
Adenomyosis with cyst greater than 2cm

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Change in adenomyotic changes of uterus adenomyotic foci either focal or diffuse location asymmetrical myometrial thickening endometrial thickness in USG Pelvis TVS finding	at 3 month

Secondary Outcome

Outcome	TimePoints
Change in duration of menstrual bleeding, amount of menstrual bleeding, chronic pelvic pain, dysmenorrhea,dyspareunia,improvement in quality of life	at every 1 month for 3 consecutive month

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2

Date of First Enrollment (India)

01/02/2026

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="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

Vataja Yonivyapada is an important gynecological disorder described in Ayurveda, characterized by symptoms such as severe dysmenorrhea, pelvic pain, and menstrual irregularities, which closely resemble the clinical features of adenomyosis in modern medicine. Adenomyosis significantly affects the quality of life of women of reproductive age, and conventional treatments are often limited to hormonal therapy or surgery.

Matra Basti is considered the prime therapy for Vata disorders, while Bala Taila possesses Vata-shamaka, balya, and vedanasthapaka properties. Maharasnadi Kwatha and Yogaraja Guggulu are classical formulations known for their Vata-Kapha shamana, shothahara, and analgesic actions. The combined use of these interventions may help in alleviating pain, regulating menstruation, and improving overall well-being.

The present single-arm clinical trial is designed to evaluate the efficacy of Matra Basti with Bala Taila along with oral administration of Maharasnadi Kwatha and Yogaraja Guggulu in the management of Vataja Yonivyapada (adenomyosis). The study aims to assess changes in subjective symptoms and overall clinical improvement, thereby exploring a safe and effective Ayurvedic management approach for this condition.