| CTRI Number |
CTRI/2026/02/103607 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic medicines and Local Therapy in managing painful menstrual bleeding among women of age group 20 - 45 with Adenomyosis |
|
Scientific Title of Study
|
Effect of selected Ayurvedic interventions in Dysmenorrhea due to 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 |
Aaryasree S Nair |
| Designation |
PG Scholar, Dept of Stri Roga and Prasuti Tantra |
| Affiliation |
Government Ayurveda Medical College and Hospital , Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital , Pulimoodu junction , Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
09388001646 |
| Fax |
|
| Email |
aaryasreekanth89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aaryasree S Nair |
| Designation |
PG Scholar, Dept of Stri Roga and Prasuti Tantra |
| Affiliation |
Government Ayurveda Medical College and Hospital , Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital , Pulimoodu junction , Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
09388001646 |
| Fax |
|
| Email |
aaryasreekanth89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha ST |
| Designation |
Professor , Dept of Stri Roga and Prasuti Tantra |
| Affiliation |
Government Ayurveda Medical College and Hospital , Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital , Pulimoodu junction , Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9745073543 |
| Fax |
|
| Email |
ashaeaswar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital , Pulimoodu junction , Thiruvananthapuram , 695001 , Kerala , India |
|
|
Primary Sponsor
|
| Name |
Aaryasree S Nair |
| Address |
PG Scholar , Government Ayurveda Medical College and Hospital , Pulimoodu , Thiruvananthapuram
695001
Kerala
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 |
| Aaryasree S Nair |
Government Ayurveda Hospital for Women and Children , Poojappura , Thiruvananthapuram |
Dept of Stree Roga and Prasuti Tantra , OP No - 1
Thiruvananthapuram
KERALA |
9388001646
aaryasreekanth89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe , Government Ayurveda College Thiruvananthapuram,Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Matrabasti | (Procedure Reference: Ashtangahridaya Sutrasthana, Procedure details: Matrabasti with 72mL Sahacharadi taila vastipaka 7 days from the day after menstrual bleeding stops in the second and third cycles )
(1) Medicine Name: Sahacharadi taila vastipaka, Reference: Ashtanga hridaya chikitsa sthana, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: sos, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asoka twak kashaya, Reference: Bhavaprakasa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: 30 minutes before food(2) Medicine Name: Guggulu panchapala choorna, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Honey 12mL), Additional Information: 30 minutes after food | | 3 | Intervention Arm | Procedure | - | Vaginal infiltration - Yoni purana | (Procedure Reference: Charakasamhitha yonivyapad chikitsa, Procedure details: 15 mL of Gugguluthikthakam ghrita is instilled into the vagina using a 5mL syringe done three times and retained for 10 minutes for 3 days on 2nd and 3rd consecutive cycles following matravasti)
(1) Medicine Name: Gugguluthikthakam ghrita, Reference: Ashtangahridayam chikitsasthana, Route: Vaginal, Dosage Form: Ghrita, Dose: 15(ml), Frequency: sos, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 20 - 45 diagnosed as dysmenorrhea with adenomyosis in USG
Interval of menstrual cycle 21 - 35 days cycles |
|
| ExclusionCriteria |
| Details |
Severe anemia
Early pregnancy and Lactating women
Diagnosed cases of Malignancy
Congenital anomalies of the Reproductive tract in USG
Hormonal Therapy for more than three months
Thyroid dysfunction
Uncontrolled and severe systemic illness
Contra indicated for matravasti and vaginal infiltration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dysmenorrhea will be assessed using Visual Analogue Scale |
At the end of each cycles(1st, 2nd and 3rd cycles) for 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menorrhagia will be assessed using Pictorial Blood Loss Assessment Chart |
At the end of each cycles(1st, 2nd and 3rd cycles) for 3 consecutive cycles |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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
|
Adenomyosis is characterized by benign ingrowth of endometrial glands and stroma into the myometrium and presents with dysmenorrhea menorrhagia dyspareunia and infertility due to abnormal uterine contractions adenomyotic foci tissue edema and prostaglandins, showing tridosha involvement and requiring drugs with vatasamana vedanasthapana rakthasangrahaka rakthapittahara and kaphahara properties. Asoka reduces pain bleeding and endometrial ingrowth, Guggulu panchapala choorna relieves pain and controls ingrowth, Sahacharadi taila matrabasti helps in pain management, and vaginal infiltration with Gugguluthikthakam ghrita supports reduction of pain and uterine enlargement. Participants aged 20 to 45 years with USG confirmed adenomyosis will be selected after informed consent and treated with Asoka twak kashaya and Guggulu panchapala choorna followed by matrabasti and vaginal infiltration in specified cycles, and dysmenorrhea and menorrhagia will be assessed for three consecutive cycles using Visual Analogue Scale and Pictorial Blood Assessment Chart. |