| CTRI Number |
CTRI/2026/02/104287 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti for the management of Uterine Fibroid. |
|
Scientific Title of Study
|
A Comparative Clinical trial to evaluate the efficacy of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti in the management of Garbhashayagata Arbuda with special reference to Uterine Fibroid. |
| 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 Vertika Chaturvedi |
| Designation |
MS SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow Uttar Pradesh |
| Address |
Post Graduate Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital,Tulsidas Marg, Old Haiderganj, Turiyaganj, Lucknow Uttar Pradesh
Post Graduate Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital,Tulsidas Marg, Old Haiderganj, Turiyaganj, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8528226785 |
| Fax |
0 |
| Email |
vertika.chaturvedi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Sharma |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow Uttar Pradesh |
| Address |
Post Graduate Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital,Tulsidas Marg, Old Haiderganj, Turiyaganj, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8743976379 |
| Fax |
0 |
| Email |
drshikhasharma1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Sharma |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow Uttar Pradesh |
| Address |
Post Graduate Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital,Tulsidas Marg, Old Haiderganj, Turiyaganj, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8743976379 |
| Fax |
0 |
| Email |
drshikhasharma1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow Uttar Pradesh 226004, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital, Lucknow |
| Address |
State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow Uttar Pradesh 226004, India |
| Type of Sponsor |
Government medical college |
|
|
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 Vertika Chaturvedi |
State Ayurvedic College and Hospital, Lucknow |
Room Number 7, OPD Number 7, Post Graduate Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital, Tulsidas Marg, Old Haiderganj, Turiyaganj, Lucknow Uttar Pradesh 226004 India
Lucknow
UTTAR PRADESH |
08528226785
0
vertika.chaturvedi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N858||Other specified noninflammatory disorders of uterus. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lekhaniya Mahakashaya Ghanvati, Reference: Charak Samhita Sutra Sthan Chapter 4/8-3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak Siddhi Sthan, Procedure details: Poorva Karma – Snehana (oleation) with Vatashamaka Taila ( Tila Taila) on the lower abdomen, back, and lower limbs followed by swedana ( Baluka Swedana) will be given to patients before each Uttarbasti. Examination of pulse and blood pressure will be done before procedure. Patient will be asked to lie in lithotomy position.
Pradhan karma – The genital parts (already shaved) will be cleaned with antiseptic solution. The vagina and cervix will be visualized with the help of the Sim’s speculum and anterior vaginal wall retractor. The anterior lip of the cervix will be held with the help of vulsellum forcep. Uterine sounding will be done and then Uttarbasti cannula, already attached with 5 mL syringe filled with Lekhaniya Mahakashaya Siddha Taila will be passed into the uterine cavity after making a head low position. The drug will be pushed above the level of the Internal Os with constant force. Pichu will be placed in vagina. The patient will be sent to bed.
Pashchat karma- Patient will be kept in head low position for ½ hour. Pulse and blood pressure will be monitored. Pichu will be removed after 2 hours.
)
(1) Medicine Name: Lekhaniya Mahakashaya Siddha Taila , Reference: Charak Samhita Sutra Sthan Chapter 4/8-3, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married female of age group between 22 to 45 years
2. Patients having Fibroid size less than or equal to 5 centimeter as per USG report with or without associated symptoms
3. Single or multiple Fibroids upto 3
4. Patients willing to participate and giving informed consent
|
|
| ExclusionCriteria |
| Details |
1. Married female below the age of 22 and above the age of 45 years
2. Patient having Fibroid size more than 5cm and number of Fibroids more than 3 as per USG report
3. Patients having Submucosal Fibroids
4. Pregnant women and lactating mothers
5. Patient coming with Hb less than 9 gm per dl
6. Patient using intra-uterine contraceptive device or taking OCPs
7. Patient suffering from any other pelvic pathology like Ovarian tumour, Tubo ovarian mass, Endometriosis, PID, Malignancy, Cervical Polyp etc
8. Patient suffering from any systemic illness like Hypertension, Tuberculosis, Cardiac disorders, etc
9. Patients with acute and chronic inflammatory disease eg- UTI, HIV, HBsAg, VDRL, HCV etc
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti in the management of Garbhashayagata Arbuda with special reference to Uterine Fibroid.
2.To study etiopathogenesis of Garbhashayagata Arbuda with special reference to Uterine Fibroid. |
Follow up during the trial at the end of every month and one month after the completion of trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To screen & compile all Ayurvedic literature available on Garbhashayagata Arbuda & its correlation with modern science.
2.To provide comparatively safe, cost effective, non-hormonal & non-surgical treatment for Uterine Fibroid patients.
3.To study the complications of trial drug if any, during & after the procedure.
|
Follow up during trial at the end of every month & one month after completion of trial. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="5"
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
|
This is a Randomised, comparative clinical study Phase 2 Parallel group trial. Comparing the efficacy of Lekhaniya Mahakashaya based Ghanvati and Siddha Taila Uttarbasti in the management of Garbhashayagata Arbuda with special reference to Uterine Fibroid for 3 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Garbhashayagata Arbuda will be randomly selected from OPD/IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group-A- In this group patients will be treated with Lekhaniya Mahakashaya based Ghanvati orally 2 Ghanvati BD Pragbhukata with Ushnodaka Anupana for the period of 3 months. Group-B- In this group patients will be treated with Lekhaniya Mahakashaya based Ghanvati orally 2 Ghanvati BD Pragbhukata with Ushnodaka Anupana for the period of 3 months along with Lekhaniya Mahakashaya Siddha Taila Uttarbasti of 3-5 ml by intra-uterine route for the period of 3 days for 3 consecutive cycles after the clearance of menses. Follow up period will be 30 days after the completion of trial. |