| CTRI Number |
CTRI/2024/07/071423 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of drinking guggulutikthakam kashayam along with oil enema using sahacharadi taila for reducing pain due to the inflammation of uterine lining |
|
Scientific Title of Study
|
Combined Effectiveness Of Guggulutikthakam Kashaya pana and Sahacharadi taila Matravasti for Management of Pain in EndometriosisS. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Husni S |
| Designation |
PG Scholar,Dept of Prasutitantra and Sthiroga |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital,Pullimoodu junction, Thiruvananthapuram, Kerala
Dept of Prasutitantra and Striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496835719 |
| Fax |
|
| Email |
esshusni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Husni S |
| Designation |
PG Scholar,Dept of Prasutitantra and Sthiroga |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital,Pullimoodu junction, Thiruvananthapuram, Kerala
Dept of Prasutitantra and Striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496835719 |
| Fax |
|
| Email |
esshusni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya Balakrishnan |
| Designation |
Professor, Dept of Prasutitantra and Striroga |
| Affiliation |
Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
| Address |
Govt Ayurveda Medical College and Hospital, Pullimoodu junction, Thiruvananthapuram
Kerala.
Dept of Prasutitantra and striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9961475750 |
| Fax |
|
| Email |
bettysunil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Pullimoodu jn, Thiruvananthapuram,695001
Kerala, India |
|
|
Primary Sponsor
|
| Name |
Husni S |
| Address |
PG Scholar, Govt Ayurveda Medical College and Hospital Pulimoodu junction 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 |
| Dr Husni S |
Govt Ayurveda Hospital for women and children,Poojappura,Thiruvananthapuram |
Dept of Prasutitantra and Striroga, OP N0- 1
Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA |
9496835719
esshusni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Govt Ayurveda College,Thiruvananthapuram, Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N809||Endometriosis, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulutikthakam kashaya, Reference: Ashtangahrudaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Carakasamhita, Procedure details: 60ml Taila administered, from the day after menstrual bleeding stops for 7 days in 3 consecutive cycles)
(1) Medicine Name: Sahacharadi taila, Reference: Ashtangahrudaya, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Subjects, who are diagnosed with endometriosis and with any one or more of the symptoms like dysmenorrhea, dyspareunia and chronic pelvic pain. |
|
| ExclusionCriteria |
| Details |
Endometriosis at remote site
Uncontrolled systemic and chronic illness.
pregnancy and lactation.
irregular cycles
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dysmenorrhea dyspareunia, and chronic pelvic pain |
0th day,31st day,61st day,91st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in size of endometrioma |
0th day, 91st day. |
|
|
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)
|
08/08/2024 |
| 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 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
|
Endometriosis is a chronic disease, characterized by implantation and growth of endometrial tissue outside the uterine cavity. Dysmenorrhea, dyspareunia and chronic pelvic pain are the most common symptoms. presence of endometrioma is often associated with endometriosis.Endometriosis is a tridosajanya vyadhi. Vitiated vata contributes to pain, pitta the inflammation and kapha the adhesions and endometrioma. Guggulutikthakam kashaya is kaphapitta samana and vatanulomana is widely used and found to help in relieving pain. Sahacharadi taila has an indication in yoniroga is widely used in gynaecological clinical practise for matravasti. Subjects in the age group of 20-45 years with all inclusion and exclusion criteria are selected from the OPD. Guggulutikthakam kasaya 48ml given internally twice daily 1 hour before food and Sahacharadi taila vastipaka given as matravasti at the dose of 60ml from the day after menstrual bleeding stops for 7 days. This combined treatment will be continued for 3 consecutive cycles. Change in dysmenorrhea, dyspareunia and chronic pelvic pain can be assessed on 0th,31st ,61st,91st day of study and 121st day for follow up, assessment done by visual decriptive scale and visual analogue scale. Also change in size of endometrioma is assessed on 0th day and 91st day by Ultrasoundsonography. |