| CTRI Number |
CTRI/2026/02/104684 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to compare the effect of Maalkanganyadi churna and Shivlingi beej churna in the treatment of Female Infertility. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Maalkanganyadi Churna and Shivlingi Beej Churna in the management of Bandhytava. |
| 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 Charu Lata |
| Designation |
Senior Lecturer |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra H.P |
| Address |
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8411840183 |
| Fax |
|
| Email |
Charugupta_sol@yahoo.Co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Soni Kapil |
| Designation |
HOD and Professor , Prasuti Tantra evum stree roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra H.P |
| Address |
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Verma |
| Designation |
PG Scholar Prasuti Tantra evum stree roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra H.P |
| Address |
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
P.G.Dept. PTSR, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 176115 Dist.Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805773474 |
| Fax |
|
| Email |
vshweta141@gmail.com |
|
|
Source of Monetary or Material Support
|
| HP Charak pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra, HP, Research Institute in ISM
Jogindernagar , Distt Mandi HP |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
Dept. of Ayurveda, Himachal Pradesh Secretariat, Shimla 171002 , H.P. Shimla |
| 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 Charu Lata |
IPD/OPD210 |
Deptt. of PTSR room no. 204 Rajiv Gandhi Government Ayurvedic College and Hospital Paprola Distt. Kangra
Hamirpur
HIMACHAL PRADESH |
8411840183
charugupta_sol@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Maalkanganyadi churna, Reference: Amritsaagarsangreh, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: shital jal), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shivlingi beej , Reference: Bhaawprakash madhay khand chikitsa 70/31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: godugadh), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. known case of infertility w.s.r to anovulation and endometrial insufficiency
2. Patient of age group 20 -35 years
3. Semen Analysis of male counterpart should be normal
4. Fallopian tubes must be patent
|
|
| ExclusionCriteria |
| Details |
1.Female less than 20 yrs and more than 35yrs of age.
2.Infertility due to abnormality in male partner.
3.Bilateral tubal blockage.
4.Uterine pathologies like cervical stenosis, cervical mucoid and fibroid polyps , fibroid uterus size (equal to or greater than 3cm)etc .
5.Congenital / Acquired anatomical abnormalities of female genitalia.
6.Patient suffering from diseases such as uncontrolled diabetes-mellitus, genital tuberculosis , renal disorder etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 100% improvement in ovulation. |
three follow ups for 3 consecutive cycles after clearence of menses. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 100% improvement in ovulation with or without conception. |
three follow ups for 3 consecutive cycles after clearence of menses. |
|
|
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 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="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
|
Research report will be soon published after the completion of trial 30 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of department of Prasuti Tantra evum Stri Roga , RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP. Patients will be divided into 2 groups of 15 each .1. Patient will be managed with Maalkanganyadi Churna with shital jal orally. 2 Patient will be managed with Shivlingi Beej Churna with koshan godugadh orally . Duartion of trial: 1. after clearance of mense for consecutive 3 cycles for 3 month Folllow up 1.Patient will be followed up monthly for 3 months .
|